Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Breast Diseases

Skin Diseases

A MRL of the axilla will be performed before and after administration of a single IV bolus injection of gadofosveset of an equivalent of 0.03 mmol Gd/kg body weight at an injection speed of 1.5 mL/sec., followed by a saline flush of 25 mL at an injection speed of 1.5 mL/sec.

Gadofosveset enhanced MRL of axillary lymph nodes

R.G.H. Beets-Tan, MD, PhD

The aim of this study is to examine the diagnostic performance of gadofosveset enhanced magnetic resonance imaging lymphography (MRL).

The diagnostic performance of MRL will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. The pathologic examination of the sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be regarded as the golden standard for nodal involvement.

Nodal Staging in Breast Cancer With MRL

Non-invasive Nodal Staging in Breast Cancer With Magnetic Resonance Imaging Lymphography Using Gadofosveset

The main study parameter will be the diagnostic performace (sensitivity, specificity, NPV and PPV) of the axillary MRL in predicting the involvement of metastases in the investigated lymph nodes. Each node will be scored on MRL as 0= benign, 1=malign. These results will be compared with the histopathological results of the SNLB procedure of ALND procedure on an node by node basis. So the diagnostic performace can be calculated.

Maastricht University Medical Center

Neoplastic Processes

All Drugs and Chemicals

Anti-Infective Agents

Bone Density Conservation Agents

Fluorides

Fluorodeoxyglucose F18

Deoxyglucose

Listerine

Sodium Fluoride

Diphosphonates

Methylene diphosphonate

Technetium Tc 99m Medronate

Protective Agents

Radiopharmaceuticals

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

Positron Emission Tomography (PET) scan

Radiolabel for positron emission tomography scan procedures

18F-Fludeoxyglucose (18F-FDG)

Computed Tomography (CT) scan

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

Andrei Iagaru, MD

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.

Stanford University

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

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)

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

Sensitivity

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

Cohort 2 - WB-MRI Scan

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

Assessment to define the accuracy of the combined 18F-NaF CT \& 18F-FDG PET/CT 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-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 utility of the 99mTc-methyl diphosphonate (MDP) bone scintigraphy scan procedure.

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

99mTc-methyl diphosphonate: Radiolabel for bone scan procedures

Cohort 2 - 99mTc-MDP Bone Scintigraphy Scan

Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions

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

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 magnetic resonance imaging (WB-MRI) scan procedure.

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 Magnetic Resonance Imaging (WB-MRI) Scan

Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI

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

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 99mTc-methyl diphosphonate (MDP) bone scan procedure.

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

99mTc-methyl diphosphonate: Radiolabel for bone scan procedures

Cohort 2 WB-MRI & 99mTc-MDP Bone Scintigraphy

Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy

Assessment to define the utility of 99mTc-methyl diphosphonate (MDP) whole-body bone scintigraphy (WBBS)

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

99mTc-methyl diphosphonate: Radiolabel for bone scan procedures

Cohort 3 - 99mTc-methyl Diphosphonate (MDP) Bone Scan

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

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 - 18F-NaF / 18F-FDG PET/MRI

Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI

Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI

Overall Study

A MRI of the Axilla will be performed before and after administration of a single IV bolus injection of gadofosveset of an equivalent of 0.03 mmol Gd/kg body weight at an injection speed of 1.5 mL/sec., followed by a saline flush of 25 mL at an injection speed of 1.5 mL/sec.

Gadofosveset contrast agent enhanced MRI Axilla

R. Beets - Tan, MD, PhD

The aim of this pilot-study is to examine the accuracy of gadofosveset enhanced MRI compared to current nodal staging methods.

The accuracy of MRL will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. The pathologic examination of the SNLB or ALND will be regarded as the golden standard for nodal involvement.

Gadofosveset for Axillary Staging in Breast Cancer Patients

Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study

The main study parameter will be the accuracy (sensitivity, specificity, NPV and PPV) of the MRI in predicting the involvement of metastases in the investigated lymph nodes. Each node will be scored on MRI as 0= benign, 1=malign. These results will be compared with the histopathological results of the SNLB procedure of ALND procedure on an node by node basis. So the accuray can be calculated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nodal Staging in Breast Cancer With MRL	NCT01609920	Breast Neoplasm...	Gadofosveset en...	18 Years -	Maastricht University Medical Center
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
Gadofosveset for Axillary Staging in Breast Cancer Patients	NCT01437865	Breast Neoplasm...	Gadofosveset co...	18 Years -	Maastricht University Medical Center

Spots Global Cancer Trial Database for gadofosveset

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