All Drugs and Chemicals

Radiopharmaceuticals

Patients receive 68Ga-FAPI IV and then undergo PET/CT approximately 1 hour later.

68Ga-FAPI is quinoline based PET radiopharmaceutical.

68Ga-FAPI is administered intravenously (IV)

68Ga-FAPI

Participants will have a CT scan for attenuation correction and anatomic localization of PET data.

Computed Tomography (CT) scan

Positron Emission Tomography (PET) scan

Risa Jiron

Carina A Mari, MD

This feasibility trial studies the use of gallium-68 (68Ga)-FAPI as the imaging agent for positron emission tomography (PET)/computed tomography (CT), collectively PET/CT, in patients with various cancers. PET uses a radioactive substance called 68Ga-FAPI, which attaches to cancer activated fibroblasts. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy tissue. CT uses X-rays to make a picture of areas inside the body. Using 68Ga-FAPI in diagnostic procedures, such as PET/CT, may allow doctors to identify smaller tumors than standard imaging.

PRIMARY OBJECTIVE:

To assess feasibility and biodistribution of PET imaging in malignancy using 68Ga-FAPI.

OUTLINE:

Patients receive 68Ga-FAPI intravenously (IV) and then undergo PET/CT approximately 1 hour later.

After completion of study, patients are followed up at 24-72 hours.

68-Ga-FAPI PET Imaging in Malignancy

68Ga-FAPI PET Imaging in Malignancy

Feasibility of 68Ga-FAPI PET/CT imaging will be done to assess patients with malignancy. Feasibility will be measured using Likert scale (1-non diagnostic; 5-excellent; anything 3 or more is diagnostic). The study will be feasible if \> 50% of scans will have a score of 3 or more

Stanford University

Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Carcinoma

Adenocarcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anticoagulants

Bone Density Conservation Agents

Amino Acids

Gallium 68 PSMA-11

Edetic Acid

Pentetic Acid

Chelating Agents

Calcium

Calcium, Dietary

Lysine

Patients receive 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11). Participant will be injected IV with 3 to 7 millicurie (mCi) of 68Ga-PSMA-11. Beginning 50 to 100 minutes later, a low-dose computed tomography (CT) scan will be obtained from vertex to mid thighs; followed by a static positron emission tomography (PET) scan over the same .

PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).

68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11), administered by intravenous (IV) injection.

68Ga-PSMA-11

Positron Emission Tomography (PET)

Andrei Iagaru, MD

The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.

PRIMARY OBJECTIVES:

I. To evaluate 68Ga-PSMA-11 PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA. PSMA refers to prostate-specific membrane antigen.

Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-PSMA-11 and undergo a PET/CT. Participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring adverse events. Clinical follow up of participant at 3 to 12 months following the scan in order to analyze secondary endpoints.

68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment

68-Ga PSMA 11 PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy in Patients With Elevated PSA

Participants had suspected prostate cancer recurrence, and were evaluated with 68Ga-PSMA-11 PET/CT and by conventional methodologies, eg, histopathology/biopsy and/or conventional imaging. The outcome will be reported as the percentage of participants for whom the 68Ga-PSMA-11 PET/CT scan was positive (confirmed by conventional methodologies) or negative (not confirmed by conventional methodologies). The outcome is reported as the number of participants without dispersion. Up to 1 year was allowed for result by the conventional methodology.

68Ga-PSMA-11 PET/CT sensitivity and specificity were assessed by comparing 68Ga-PSMA-11 PET/CT scan results with conventional imaging follow-up and/or histopathology/biopsy within the following 1 year. Sensitivity is a percentage that estimates, within a group of participants, the proportion within that group that truly has a disease or condition. Specificity is a percentage that estimates, within a group of participants, the proportion within that group that truly does not have the disease or condition. The outcome is reported as the point estimates for sensitivity and specificity, given as percentages representing agreement between the 68Ga-PSMA-11 PET/CT scan result and the conventional assessment, and the 95% CI. A higher point estimate represents better agreement between the methodologies.

Positive predictive value (PPV) is the probability that participants with a positive screening test truly have the disease, and negative predictive value (NPV) is the probability that participants with a negative screening test truly do not have the disease. Predictive Value for 68Ga-PSMA-11 PET/CT was assessed by evaluating scans of the prostate, pelvic lymph nodes, paraaortic lymph nodes, mediastinal lymph nodes, bone, and lung. The outcome is reported as the probability as a percentage and the 95% CI.

Scan quality was assessed by sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) determinations for the 68Ga-PSMA-11 PET/CT scans in participants stratified by prostate-specific antigen (PSA) level in ng/mL. Stratification levels were as follows.

* 0.2 to \< 0.5
* 0.5 to \< 1.0
* 1.0 to \< 2.0
* 2.0 to \< 5.0
* ≥ 5.0, The outcome is expressed as the Sensitivity, Specificity, PPV, and NPV values observed for the PSA level strata, with 95% confidence interval.

Andrei Iagaru

Professor of Radiology

Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.

* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT

Diagnostic (68Ga-PSMA-11 PET/CT)

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Andrei Iagaru, Professor of Radiology (Nuclear Medicine)

Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT

Sensitivity

Specificity

68Ga-PSMA-11 PET/CT Sensitivity and Specificity

Positive predictive value (PPV)

Negative predictive value (NPV)

68Ga-PSMA-11 PET/CT Predictive Value by Region

Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.2 to < 0.5 ng/m?

Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.5 to < 1.0 ng/mL

Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 1.0 to < 2.0 ng/mL

Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 2.0 to < 5.0 ng/mL

Diagnostic (68Ga-PSMA-11 PET/CT) for PSA ≥ 5.0 ng/mL

Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level

Overall Study

Skin and Connective Tissue Diseases

Wounds and Injuries

Breast Neoplasms

Radiation Injuries

Breast Diseases

Skin Diseases

The participants in this group will be receiving proton therapy of the affected breast and chest wall as part of their standard of care. In addition, a Computed Tomography (CT) Scan of the chest wall will be performed, and pulmonary function test (PFT).

The participants in this group will be receiving X-ray radiation therapy of the affected breast and chest wall as part of their standard of care. In addition, a Computed Tomography (CT) Scan of the chest wall will be performed, and pulmonary function test (PFT).

Proton bean radiation therapy interact differently with tissue with the result that protons are absorbed completely within the tissue instead of primarily passing through the entire body. The maximal depth of penetration is dependent upon the incoming velocity (energy) of the protons. Proton therapy utilizes this property to deliver radiation with very little dose beyond the targeted lesion. The dose-rate will be managed as part of the standard of care.

Proton beam radiation therapy.

The three-dimensional (3D) mapping of radiation dose distributions permits detailed assessment of local vascular damage as a function of treatment factors of dose, dose-rate. The dose-rate will be managed as part of the standard of care.

X-ray based radiation therapy

Computed Tomography (CT) Scan of the chest will be performed at 1, 3, 6, 12, 18 and 24 months

Computed Tomography (CT) Scan

Pulmonary function test (PFT) will be performed at pre-treatment, and at 6 and 12 months.

Pulmonary Function Test (PFT)

Walter O'Dell, PhD

Julie Bradley, PhD

Through improved early detection and treatment, the number of long term breast cancer survivors continues to increase. There are now 2.8 million breast cancer survivors in the U.S. Florida alone adds over 9,000 women to the survivorship pool each year. Most receive radiation treatment (RT) of the affected breast and chest wall to reduce risk of recurrence. Even with advanced radiation techniques for dose conformality to minimize exposure of the highly sensitive lung, 14% of breast cancer patients treated with radiation develop clinical pulmonary toxicity, with 4% overall experiencing high grade clinical toxicity. Early diagnosis and intervention to mitigate lung radiation toxicity is increasingly important for the long term care of these survivors.

The investigators' goal is to better identify breast cancer patients at high risk for experiencing severe pulmonary toxicity requiring medical intervention, provide a means to identify toxicity early on, and tailor treatment and/or early intervention on a per-patient basis.

This project involves repeat chest computed tomography (CT) imaging and blood draws in subjects with breast cancer with radiation treatment to the affected breast and chest wall. The investigators are studying women receiving one of 2 types of radiation, either conventional X-rays (IMRT) or protons at the University of Florida Health Proton Therapy Institute (UFHPTI). These subjects typically would not receive follow-up chest CTs as per standard of care. All subjects will have received a pre-treatment chest CT scan as part of the treatment planning process. The investigators will enroll 30 subjects in the X-ray treatment group and 25 subjects in the proton group.

The investigative team has recently solved the technical challenges of extracting and characterizing lung vascular anatomy from clinical CT images of the chest and used these tools to characterize acute and chronic changes to pulmonary vascular structure in breast cancer patients receiving radiation to the chest wall for treatment of their cancer.

In Aim 1 of this study the investigators will compare lung vascular damage in women treated with conventional radiation with those treated at the UFHPTI. In Aim 2 they will use blood samples of the subjects of Aim 1 to investigate the differential role of inflammatory cytokines in the initiation and progression of pulmonary vascular radiation response in conventional versus proton radiation exposures. Aim 3 compares vascular damage with clinical pulmonary function assessment using spirometry and diffusion capacity of carbon monoxide (DLCO). Aim 4 ties together Aims 1-3 by employing and extending existing mathematical models of radiobiological response to improve and solidify the scientific understanding of the biological mechanisms of radiation response.

Breast Cancer Lung Late Effects

Early Markers of Subclinical Pulmonary Vascular Radiation Toxicity in Breast Cancer

To identify patterns of asymptomatic metastatic progression in those subjects who develop recurrence to the thorax during the follow-up imaging period,

The investigators seek to identify differences between the treatment modalities (proton versus X-ray) in regards to the lower dose limits for change in number of small blood vessels as measured from chest CT scans and quantified using the team's analysis technique.

Identify change in number of small blood vessels as measured from chest CT scans and quantified using the team's analysis technique, as a function of radiation dose exposure across the lung.

Identify differences in temporal patterns of vessel regeneration following radiation exposure as a function of dose and of modality (proton versus X-ray).

Quantify differences in temporal patterns of levels of cytokines in the blood in breast cancer patients receiving conventional X-ray versus proton RT using serial blood draws that are time-matched with the CT chest scans.

Correlate change in number of small blood vessels as measured from chest CT scans and quantified using the team's analysis technique, with clinical pulmonary function test (spirometry and diffusion capacity for carbon monoxide) outcomes to identify potential predictive value of early vascular changes to conventional clinical measures of late effects.

The goal is to monitor long-term (\>8 year) incidence of clinical pulmonary toxicity in these subjects to identify any difference between X-ray and proton treatment methodologies.

The goal is to monitor long-term (\>8 year) survival in these subjects to identify any difference between X-ray and proton treatment methodologies.

Florida Department of Health

University of Florida

Neoplasm Metastasis

Neoplastic Processes

Anti-Infective Agents

Fluorides

Fluorodeoxyglucose F18

Deoxyglucose

Listerine

Sodium Fluoride

Diphosphonates

Methylene diphosphonate

Technetium Tc 99m Medronate

Protective Agents

Anti-Infective Agents, Local

Antimetabolites

Antiviral Agents

Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the combined 18F-NaF CT \& 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.

Assessment to define the accuracy of the combined 18F-NaF CT \& 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.

Assessment to define the utility of 18F-NaF \& 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.

Scan to diagnose a number of bone conditions including cancer or metastasis

Bone scan

99mTc-methyl diphosphonate

Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F

Radiolabel for positron emission tomography scan procedures

18F-Fludeoxyglucose (18F-FDG)

Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.

18F-Sodium Fluoride (18F-NaF)

Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields \& radio waves to generate images of the organs in the body.

Whole Body Magnetic Resonance Imaging (WB-MRI) scan

A gadolinium-based contrast agent for MRI

Gadopentetate dimeglumine

Gadofosveset

Gadobutrol

This clinical trial studies the use of sodium fluorine-18 (18F-NaF) plus fluorine-18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI) to detect skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate cancer.

Eligible participants had previously received a bone scan using the radiolabel 99mTc-methyl diphosphonate (t99-MDP) as part of their regular medical care.

18F-NaF and 18F-FDG are radioactive substances (radiolabels) that are absorbed by cancerous cells and allow for the cancer to be found using diagnostic procedures such as positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI). PET/WBMRI is a combination procedure that combines the detailed PET images of areas inside the body from PET with the WBMRI scans, and may help find and diagnose skeletal metastases in patients with breast or prostate cancer. It is not yet known whether 18F-NaF/18F-FDG PET/WBMRI is better than standard imaging methods in detecting skeletal metastases.

Eligible participants diagnosed with breast/prostate cancers and who have had 99mTc MDP bone scanning as part of their routine care are recruited and enrolled. Participants then receive an 18F-NaF/18F-FDG positron emission tomography (PET)/ WBMRI combination scan.

The PET/MRI scans will be interpreted by 2 American Board Nuclear Medicine (ABNM)-certified physicians and 2 American Board of Radiology (ABR)-certified radiologists, all with significant clinical experience, who are blinded to the subjects' medical history and the results of other imaging modalities.

The scans will be analyzed and compared against each other, with a consensus read will be obtained for each scan. Characterization of lesions as true-positive, true-negative, false-positive or false-negative will be done through a combination of clinical follow-up, imaging follow-up and/or histopathology findings. An overall diagnosis based on each scan will be determined on a 5-point scale (1=benign, 2=likely benign, 3=uncertain, 4=likely malignant, 5=malignant) to conduct a receiver operating characteristic (ROC) analysis.

If the diagnosis is positive for metastases on any of the scans, the investigator will identify the number of lesions and locations of positivity, and record this information.

Clinical is obtained at about 12 months after the initial scans.

Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases

The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 99mTc-methylene diphosphonate (MDP) bone scintigraphy was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18F-NaF vs 99mTc-MDP bone scintigraphy ("18F-NaF \> 99mTc-MDP"), the same between both scans ("18F-NaF = 99mTc-MDP"), or inferior for 18F-NaF vs 99mTc-MDP bone scintigraphy ("18F-NaF \< 99mTc-MDP").

The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant diagnosed with osseous (skeletal) metastases. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18-NaF PET/CT compared to 18F-FDG PET/CT, the same between both scans, or inferior for 18-NaF PET/CT compared to 18F-FDG PET/CT. The outcome result is represented as a number without dispersion.

The medical value of whole body magnetic imaging resonance (WB-MRI) vs 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of which scan detected the greater number of tumor lesions in each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom lesions detected by WB MRI was \> 18F-NaF PET/CT; equal to 18F-NaF PET/CT; or \< 18F-NaF PET/CT. The outcome result is represented as a number without dispersion.

8 analyzed 5 2

1

The medical value of whole body magnetic imaging resonance (WB-MRI) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of which scan detected the greater number of tumor lesions in each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom lesions detected by WB MRI was \> 18F-FDG PET/CT; equal to to 18F-FDG PET/CT; or \< 18F-FDG PET/CT. The outcome result is represented as a number without dispersion.

The ability of 18F-sodium fluoride (NaF) and 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) to detect osseous (skeletal) metastases was assessed. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of Cohort 1 participants for whom osseous metastases were detected, a number without dispersion.

Sensitivity; positive predictive value (PPV); and accuracy for the detection of extraskeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI).

* Sensitivity is a percentage that defines the proportion of true positive participants with the disease in a total group of participants.
* PPV is the probability that participants with a positive screening test truly have the disease.
* Accuracy is the proportion of true results (both true positives and true negatives) among the total number of cases examined.

Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity, PPV, and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.

Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.

Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.

Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.

Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.

Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, participants with skeletal lesions were identified. The outcome is reported as the number of Cohort 3 participants for whom skeletal lesions were identified by each scan methodology, a number without dispersion.

Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, the total number skeletal lesions identified in the participants was determined. The outcome is reported as the total number skeletal lesions identified by each scan methodology, a number without dispersion.

Professor of Radiology (Nuclear Medicine)

Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the combined 18F-NaF CT \& 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.

Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis

99mTc-methyl diphosphonate: Radiolabel for bone scan procedures

Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F

18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures

Computed Tomography (CT) scan: Scan to detect \& analyze X-rays

18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.

Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI

Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans

Assessment to define the accuracy of the combined 18F-NaF CT \& 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.

Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis

99mTc-methyl diphosphonate: Radiolabel for bone scan procedures

Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F

18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures

Computed Tomography (CT) scan: Scan to detect \& analyze X-rays

18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.

Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields \& radio waves to generate images of the organs in the body.

Gadofosveset: A gadolinium-based contrast agent for MRI

Gadobutrol: A gadolinium-based contrast agent for MRI

Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans

Assessment to define the utility of 18F-NaF \& 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.

Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis

99mTc-methyl diphosphonate: Radiolabel for bone scan procedures

Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F

18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures

18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.

Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields \& radio waves to generate images of the organs in the body.

Gadofosveset: A gadolinium-based contrast agent for MRI

Gadobutrol: A gadolinium-based contrast agent for MRI

Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan

Total

18F-NaF > 99mTc-MDP

18F-NaF = 99mTc-MDP

18F-NaF < 99mTc-MDP

This assessment was conducted only for Cohort 1 as part of the "pilot phase" of the study.

Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy

18F-NaF > 18F-FDG

18F-NaF = 18F-FDG

18F-NaF < 18F-FDG

This assessment was conducted only for Cohort 1, and only for participants with skeletal metastases, as part of the "pilot phase" of the study.

Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT

This assessment was conducted only for Cohort 1 as part of the "pilot phase" of the study. Only participants with medically-evaluable results for both scans are included.

Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT

Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT

Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the 18F-NaF CT \& 18F-FDG PET scan procedures.

Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F

Computed Tomography (CT) scan: Scan to detect \& analyze X-rays

18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.

Cohort 1 Pilot - 18F-NaF-CT Scan

Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the 18F-NaF CT \& 18F-FDG PET scan procedures.

Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F

18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures

Computed Tomography (CT) scan: Scan to detect \& analyze X-rays

Cohort 1 Pilot - 18F-FDG-PET Scan

This assessment was conducted only for Cohort 1 as part of the "pilot phase" of the study. Only participants with both medically-evaluable scans are included.

Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT

Positive predictive value

Accuracy

Assessment to define the utility of the combined 18F-NaF \& 18F-FDG PET/CT scan.

Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F

18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures

18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.

Cohort 2 - Combined 18F-NaF-CT/18F-FDG-PET Scan

Assessment to define the accuracy of the whole body-MRI scan.

Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields \& radio waves to generate images of the organs in the body.

Gadofosveset: A gadolinium-based contrast agent for MRI

Gadobutrol: A gadolinium-based contrast agent for MRI

Cohort 2 - Whole Body-MRI Scan

For this outcome, participants in Cohort 2 were analyzed with 2 distinct scanning procedures, ie, 18F-NaF/18F-FDG PET/CT scan and whole-body MRI scan.

Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions

Assessment to define the accuracy of the combined 18F-NaF CT \& 18F-FDG PET/CT scan.

Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F

Computed Tomography (CT) scan: Scan to detect \& analyze X-rays

18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures

18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.

Assessment to define the accuracy of the whole body MRI scan.

Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields \& radio waves to generate images of the organs in the body.

Gadofosveset: A gadolinium-based contrast agent for MRI

Gadobutrol: A gadolinium-based contrast agent for MRI

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
68-Ga-FAPI PET Imaging in Malignancy	NCT04023240	Cancer	68Ga-FAPI Computed Tomogr... Positron Emissi...	19 Years - 99 Years	Stanford University
68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment	NCT02673151	Prostate Adenoc... PSA Failure Recurrent Prost...	Computed Tomogr... 68Ga-PSMA-11 Positron Emissi...	18 Years -	Stanford University
Breast Cancer Lung Late Effects	NCT02725840	Radiation Injur... Breast Cancer	Proton beam rad... X-ray based rad... Computed Tomogr... Pulmonary Funct...	18 Years -	University of Florida
68-Ga-FAPI PET Imaging in Malignancy	NCT04023240	Cancer	68Ga-FAPI Computed Tomogr... Positron Emissi...	19 Years - 99 Years	Stanford University
Breast Cancer Lung Late Effects	NCT02725840	Radiation Injur... Breast Cancer	Proton beam rad... X-ray based rad... Computed Tomogr... Pulmonary Funct...	18 Years -	University of Florida
Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases	NCT00375830	Cancer	Bone scan 99mTc-methyl di... Positron Emissi... 18F-Fludeoxyglu... Computed Tomogr... 18F-Sodium Fluo... Whole Body Magn... Gadopentetate d... Gadofosveset Gadobutrol	18 Years -	Stanford University
Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases	NCT00375830	Cancer	Bone scan 99mTc-methyl di... Positron Emissi... 18F-Fludeoxyglu... Computed Tomogr... 18F-Sodium Fluo... Whole Body Magn... Gadopentetate d... Gadofosveset Gadobutrol	18 Years -	Stanford University
68-Ga-FAPI PET Imaging in Malignancy	NCT04023240	Cancer	68Ga-FAPI Computed Tomogr... Positron Emissi...	19 Years - 99 Years	Stanford University
Breast Cancer Lung Late Effects	NCT02725840	Radiation Injur... Breast Cancer	Proton beam rad... X-ray based rad... Computed Tomogr... Pulmonary Funct...	18 Years -	University of Florida

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