Neoplasms

All Conditions

Symptoms and General Pathology

Rare Diseases

Glioma

Disease Progression

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Single intravenous administration of 18F fluciclovine for PET-MRI Scan

18F-Fluciclovine will be injected via IV prior to Positron emission tomography (PET)-Magnetic resonance imaging (MRI)

18F-Fluciclovine PET-MRI

Ali Nabavizadeh

Hannah Anderson

Ali Nabavizadeh, MD

The purpose of this study is to see if 18F-fluciclovine (Axumin®) PET imaging is useful and safe in the management of children with High Grade Gliomas. Investigators seek to determine if this imaging will help doctors tell the difference between tumor growth (progression) and other tumor changes that can occur after treatment.

Following radiation and immunotherapy, many pediatric participants with high-grade gliomas (HGG), including diffuse midline glioma (DMG), demonstrate radiographic findings suspicious of disease progression. Differentiating post-treatment changes from true tumor progression is paramount to clinical decision-making, as true tumor progression may warrant a change in treatment, while post-treatment changes are typically not an indication to change treatment. Unfortunately, conventional MRI cannot reliably distinguish between true progression and post-treatment changes. Therefore, finding a physiological correlate to delineate true progression from pseudo-progression is critical.

The overall objective of this current application is to evaluate 18F-fluciclovine PET imaging as a diagnostic biomarker for tumor progression compared to post-treatment changes in pediatric HGG. The long-term goal of this research is to accurately differentiate tumor progression from post-treatment changes in pediatric HGG using 18F-fluciclovine PET imaging.

18F-Fluciclovine PET-MRI in High-grade Glioma

Evaluation of 18F-Fluciclovine PET-MRI to Differentiate Tumor Progression From Post-treatment Changes in Pediatric High-grade Glioma (HGG)

Comparison of Standardized uptake value (SUV) max, SUV peak, and uptake kinetics post radiation between participants who experience true progression versus those who experience pseudoprogression as confirmed by routine imaging.

Evaluation of SUV uptake post radiation in participants with planned biopsy or resection who experience true progression versus those who experience pseudoprogression as confirmed by histopathology.

The Safety profile of 18F-Fluciclovine PET in pediatric HGG participants will be assessed based on CTCAE 5.0 toxicity experienced after administration of 18F-Fluciclovine

Blue Earth Diagnostics

Dragon Master Foundation

Children's Hospital of Philadelphia

Nervous System Diseases

Neoplasm Metastasis

Recurrence

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Single intravenous administration of 18F fluciclovine for PET Scan

18F fluciclovine injection, 185 MegaBecquerel (MBq) (5 Millicurie (mCi)) ± 20%, delivered as an intravenous bolus

18F fluciclovine

Eugene Teoh, MD

Rupesh Kotecha, MD

An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy

Positron Emission Tomography (PET) Imaging study

Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)

Sensitivity is calculated as % of participants with positive histopathology who are classified as positive on their 18F fluciclovine PET (i.e. true positive). Each participant had one lesion, therefore results are representative of both subject and lesion level sensitivity.

Three readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. Three different thresholds of 18F fluciclovine uptake were then applied to calculate the sensitivity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. As an example, for calculating sensitivity based on the threshold of Mild or Higher Uptake, all participants with positive histopathology, classified by a reader as having mild, moderate or marked 18F fluciclovine uptake, would be categorized as true positive. This calculation was then repeated on the other two threshold categories, to produce sensitivities at different thresholds.

Specificity is calculated as the % of participants with negative histopathology who are classified as negative on their 18F fluciclovine PET (i.e. true negative). Each participant had 1 lesion, therefore results are representative of both subject and lesion level specificity. 3 readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. 3 different thresholds of uptake were then applied to calculate the specificity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. Example, for calculating specificity based on the threshold of Moderate or Higher Uptake, all participants with negative histopath, classified by a reader as having absent or mild uptake (i.e. not classified by a reader as having moderate or marked uptake), would be categorized as true negative. This calculation was repeated on the other 2 threshold categories, to produce specificities at different thresholds

Sensitivity calculated as %participants with positive histopath and positive on PET (i.e. true positive). Each participant had 1 lesion, results represent both subject and lesion level sensitivity. Sensitivity is calculated using positive PET classified by quantitative and dynamic measures. Quantitative measure is based on lesion standardized uptake value (SUV). Receiver Operating Characteristic (ROC) analysis of all participant lesion SUV was performed. ROC analyses was performed to select a SUV threshold for calculating sensitivity. Sensitivity calculation: participants with positive histopath and SUV = or \> threshold are positive on scan. Dynamic measure: 3 readers evaluated PET scans to classify uptake pattern based on 4 categories: Type 0, Type I, Type II, Type III. Sensitivity is calculated for each type of uptake pattern (example: calculating sensitivity based on Type I pattern, participants with positive histopath, classified as Type I, would be categorized as true positive).

Specificity is calculated as %participants with negative histopath and negative on PET (i.e. true negative). Each participant had 1 lesion, results represent both subject and lesion level specificity. Specificity is calculated using negative PET classified by quantitative and dynamic measures. Quantitative measure is based on lesion standardized uptake value (SUV). Receiver Operating Characteristic (ROC) analysis of all participant lesion SUV was performed. ROC analyses was performed to select a SUV threshold for calculating sensitivity. Specificity calculation: participants with negative histopath, SUV \< threshold are negative on scan. Dynamic measure: 3 readers evaluated PET scans to classify uptake pattern based on 4 categories: Type 0, Type I, Type II, Type III. Specificity is calculated for each type of uptake pattern (example, calculating specificity based on Type I pattern, participants with negative histopath, classified as Type I, would be categorized as true negative)

Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F fluciclovine until 1 day post-18F-fluciclovine administration.

Precision For Medicine

Subjects who have been dosed with 18F-Fluciclovine, have an evaluable on-study PET scan, and an evaluable central histopathology report from the sample obtained from the SoC craniotomy.

18F-Fluciclovine Injection

Single intravenous administration of 18F fluciclovine for PET Scan

18F fluciclovine: 18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus

Patients

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Chief Medical Officer

Mild or Higher Uptake = Positive : Central Reader 1

Mild or Higher Uptake = Positive : Central Reader 2

Mild or Higher Uptake = Positive : Central Reader 3

Moderate or Higher Uptake = Positive : Central Reader 1

Moderate or Higher Uptake = Positive : Central Reader 2

Moderate or Higher Uptake = Positive : Central Reader 3

Marked Uptake = Positive : Central Reader 1

Marked Uptake = Positive : Central Reader 2

Marked Uptake = Positive : Central Reader 3

Subjects who have been dosed with 18F-Fluciclovine, have an evaluable on-study PET scan, and positive histopathology.

Sensitivity analysis (%) based on 10 subjects with positive lesions per standard of truth (central histopathological analysis).

Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds

Subjects who have been dosed with 18F-Fluciclovine, have an evaluable on-study PET scan, and negative histopathology.

Specificity analysis (%) based on 13 subjects with negative lesions per standard of truth (central histopathological analysis).

Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds

Quantitative SUV ≥ 4.8 = Positive : Central Reader 1

Quantitative SUV ≥ 4.8 = Positive : Central Reader 2

Quantitative SUV ≥ 4.8 = Positive : Central Reader 3

Dynamic Type 0: Central Reader 1

Dynamic Type 0 : Central Reader 2

Dynamic Type 0 : Central Reader 3

Dynamic Type I: Central Reader 1

Dynamic Type I: Central Reader 2

Dynamic Type I: Central Reader 3

Dynamic Type II: Central Reader 1

Dynamic Type II: Central Reader 2

Dynamic Type II: Central Reader 3

Dynamic Type III: Central Reader 1

Dynamic Type III: Central Reader 2

Dynamic Type III: Central Reader 3

Subjects who have been dosed with 18F-Fluciclovine, have an evaluable on-study PET scan, and positive histopathology

Sensitivity analysis (%) based on 10 subjects with positive lesions per standard of truth.

Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake

SUV ≥ 4.8 : Central Reader 1

SUV ≥ 4.8 : Central Reader 2

SUV ≥ 4.8 : Central Reader 3

Dynamic Type 0 : Central Reader 1

Dynamic Type I : Central Reader 1

Dynamic Type I : Central Reader 2

Dynamic Type I : Central Reader 3

Dynamic Type II : Central Reader 1

Dynamic Type II : Central Reader 2

Dynamic Type II : Central Reader 3

Dynamic Type III : Central Reader 1

Dynamic Type III : Central Reader 2

Dynamic Type III : Central Reader 3

Specificity of 18F fluciclovine PET for detecting recurrent brain metastases based on quantitative and dynamic measures of lesion 18F fluciclovine uptake

Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake.

Subjects reporting at least 1 TEAE

Nervous System Disorders (Headache)

Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F fluciclovine until 2 days post-18F-fluciclovine administration.

Treatment-emergent Adverse Events

Overall Study

Neoplasms, Second Primary

In total, three 18F-fluciclovine PET/CT brain scans (pre-, interim-, and post-treatment) will be performed according to the study calendar. Generic name is Axumin and will be administered as an intravenous bolus. May administer diluted or undiluted. The maximum volume of undiluted 18F-fluciclovine is 5 mL. After administration, flush with normal saline to ensure full delivery of the dose.

Patients will receive a standard 5 millicuries dose of 18F-fluciclovine intravenously as a bolus injection. They will be required to fast for at least four hours prior to 18F-fluciclovine injection. Patients will be positioned for PET/CT brain imaging and will be injected with 18F-fluciclovine immediately prior to PET data acquisition. PET data will be collected in list mode up to 25 minutes post-injection. PET images will be reconstructed in two ways: as a standard static image of data acquired between 10 to 20 minutes post-injection, and as a dynamic series of four 5-minute frames between 5 to 25 minutes post-injection to allow for motion assessment and correction and time-dependent observations.

Rupesh C Kotecha, MD

Jessica Injiac

Rupesh C Kotecha

Rupesh R Kotecha, MD

The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.

This is a prospective, single-site, single-arm, phase 1 proof-of-concept study to assess the potential clinical utility of 18F-fluciclovine PET/CT as a functional integral biomarker for patients with large brain metastases (\>2 cm) treated with Staged Stereotactic Radiosurgery (SSRS).

Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery

Characterization of Large Brain Metastases With 18F-Fluciclovine PET/CT Treated With Staged Stereotactic Radiosurgery

Calculate the sensitivity of pre-treatment 18F-fluciclovine PET/CT to identify brain metastases \>2 cm treated with SSRS.

To calculate the sensitivity of pre-treatment contrast-enhanced MRI.

To identify a change in the standardized uptake value (SUV) parameters (SUVpeak, SUVmean, and SUVmax) for the 18F-fluciclovine PET/CT scans.

To calculate the pre-, interim-, and post-treatment SUV metrics of 18F-fluciclovine PET uptake

To calculate the percent change in lesion volume on contrast-enhanced MRI (∆MRIvolume).

Baptist Health South Florida

Participants will undergo a 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging (MRI). Then participants will undergo single-fraction SRS as standard of care (SOC). A second 18F-fluciclovine PET scan will be completed 8 weeks (± 2 weeks) after SRS.

Participants will receive 5-mCi dose (± 20%) of 18F-fluciclovine intravenously as a bolus injection immediately prior to PET data acquisition. PET data will be collected in list mode up to 25 minutes post-injection. PET images will be reconstructed in two ways: as a standard static image of data acquired between 10 to 20 minutes post-injection, and as a dynamic series of four 5-minute frames between 5 to 25 minutes post-injection to allow for motion assessment and correction and time-dependent observations.

Rupesh Kotecha, M.D.

Antoinette Pimental

This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)

Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVpeak will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.

Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmean will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.

Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmax will be calculated for the pre-SRS and post-SRS imaging studies, as well as the change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.

Each lesion will be followed from pre-treatment PET to local failure or retreatment; death; lost-to follow-up, discontinuation, or withdrawal; or end of study. Local failure is defined as disease progression according to Response Assessment in Neuro-Oncology (RANO) criteria.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Endometrial Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Fluorodeoxyglucose F18

Subjects with recently biopsy-proven malignancy of the cervix or uterus undergo an 18F fluciclovine PET scan on a hybrid PET/MRI scanner after they have completed a standard-of-care F-18 FDG PET/CT study.

Each subject will receive one IV dose of 18F fluciclovine for PET scanning

Each subject will undergo one 18F fluciclovine PET scan on a hybrid PET/MRI scanner

18F fluciclovine PET

Nghi C Nguyen, MD, PhD

18F Fluciclovine is a recently FDA- approved radiopharmaceutical for prostate cancer biochemical recurrence, which is only minimally eliminated by the kidneys and therefore the image interpretation is not affected by nonspecific urine activity in the ureters and bladder, which is advantageous for pelvic imaging. Recent literature suggests that Fluciclovine PET has diagnostic potential for a variety of solid tumors, thus, allowing new opportunities for noninvasive probing of glutamine metabolism and clinical use in patient management. Current literature indicates that amino acid transporters including that of glutamine are upregulated in endometrial and cervical cancer so that Fluciclovine PET may have clinical potentials. The hypothesis is that Fluciclovine PET provides better imaging properties and greater diagnostic confidence and accuracy than FDG PET does in pelvic malignancies.

Given the lack of current clinical data, a pilot study providing a direct comparison of Fluciclovine PET with FDG PET is warranted. The investigators seek to conduct a pilot study with 10 subjects to evaluate the clinical utility of Fluciclovine PET for staging of cervical cancer and endometrial cancer. This research will compare the diagnostic performance of the research Fluciclovine PET/MRI with the standard-of-care FDG PET/CT as an exploratory endpoint.

Background:

Endometrial cancer arises from the inner lining of the uterus and is one of the most common malignancies in women, representing 3.6% of all new cancer cases in the US. It is estimated that there are more than 60,000 new cases of endometrial cancer and more than 10,000 people will die of this malignancy in 2016. It is most frequently diagnosed among women aged 55-64. Cervical cancer starts in the cervix, the lower part of the uterus. Its prevalence is lower compared with endometrial cancer thank to effective screening and early disease detection with the Pap smear. In 2016, it is estimated that there will be more than 12,000 new cases of cervical cancer and more than 4,000 patients will die of this disease in the US.

Positron Emission Tomography (PET) combined with Computed Tomography (CT) is an essential part of the workup for many malignancies. F-18 FDG PET/CT is currently the standard-of-care (SOC) PET/CT modality for staging and restaging of pelvic malignancies in women. But there are certain diagnostic limitations related to F-18 FDG because it is mainly eliminated by the kidneys and often interferes with the detection of cancer lesions, particularly in the abdominal and pelvic regions. On the other hand, the recently FDA approved F-18 Fluciclovine is only minimally eliminated by the kidneys and therefore the image interpretation is not affected by nonspecific urine activity in the ureters and bladder, which is advantageous for pelvic imaging. Recent literature suggests that Fluciclovine PET has diagnostic potential for a variety of solid tumors, thus, allowing new opportunities for noninvasive probing of glutamine metabolism and clinical use in patient management.

Current literature indicates that amino acid transporters including that of glutamine are upregulated in endometrial and cervical cancer so that Fluciclovine PET may have clinical potentials. The hypothesis is that Fluciclovine PET provides better imaging properties and greater diagnostic confidence and accuracy than FDG PET does in pelvic malignancies.

Given the lack of current clinical data, a pilot study providing a direct comparison of Fluciclovine PET with FDG PET is warranted.

Objective:

The investigators seek to conduct a pilot study to evaluate the clinical utility of Fluciclovine PET for staging of cervical cancer and endometrial cancer. This research will focus on pelvic imaging comparing the diagnostic performance of the research Fluciclovine PET/MRI with SOC FDG PET/CT as an exploratory endpoint. Dynamic PET imaging on a hybrid PET/MR scanner will provide valuable pharmacokinetic information that can be used to identify the optimal time window for the detection and characterization of the primary tumor and pelvic nodal disease. Additional abdominal imaging will allow for further correlation with FDG PET/CT in terms of nodal disease and distant metastasis detection. As previously demonstrated in prostate cancer, the Fluciclovine uptake can be heterogeneous which may have diagnostic and prognostic implications. Therefore, this pilot study will provide valuable information on potential Fluciclovine heterogeneity in cervical and uterine cancer. Textural heterogeneity of the primary will be compared between Fluciclovine and FDG PET. The initial experience gained with this pilot study will provide valuable insights into the pharmacokinetics and textural heterogeneity of Fluciclovine PET in cervical and uterine cancers, and presents the first data on the potential strengths and weaknesses of Fluciclovine PET/MR compared with FDG PET/CT.

1. The investigators hypothesize that Fluciclovine PET is non-inferior to FDG PET regarding detection of the primary tumor.
2. It is hypothesized that nodal disease staging is more accurate with Fluciclovine than with FDG PET because of the low level of nonspecific urinary bladder and ureter activity.
3. It is hypothesized that the dynamic uptake pattern of the primary lesion correlates with the tumor grading on histopathology.
4. It is hypothesized that textural heterogeneity is different between Fluciclovine and FDG PET.

Specific Aims:

* To study the pharmacokinetics of Fluciclovine PET in women with cervical and uterine cancers
* To characterize physiologic uptake pattern of the uterus and ovaries when these are not affected by tumor.
* To identify the optimal time window for the quantitative analysis of Fluciclovine primary and pelvic nodal disease
* To correlate the time-activity curve pattern of the primary lesion with histopathologic tumor grading
* To compare diagnostic performance of Fluciclovine PET and FDG PET
* To compare textural heterogeneity of the primary between Fluciclovine PET and FDG PET

Significance:

The initial experience gained with this pilot study will provide valuable insights into the pharmacokinetics, lesion detectability and textural heterogeneity of Fluciclovine PET in cervical cancer and uterine cancer. The study provides preliminary data on the potential strengths and weaknesses of Fluciclovine PET/MR compared with the SOC FDG PET/CT.

Fluciclovine PET may provide a significant improvement in the TNM staging compared with FDG PET as it is not affected by nonspecific urine activity in the ureters and bladder, which is a common diagnostic problem for FDG PET. By combining the excellent soft-tissue contrast of MRI with Fluciclovine PET, the hybrid PET/MR scanning could be a convenient and effective one-stop imaging procedure providing both pelvic TNM staging and whole-body M staging. Moreover, valuable prognostic information may be derived from Fluciclovine PET pharmacokinetics and heterogeneity assessment as well as multi-parametric PET/MR evaluation.

Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer.

Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer Compared With 18F FDG PET

There is not a plan to make IPD available for this pilot study.

Metabolic parameter of maximum standard-uptake-value (SUV) will be compared between research Fluciclovine PET and standard-of-care FDG PET to determine lesion metabolic avidity

The optimal time window for tumor detection (primary, nodal metastasis) relative to physiologic and benign structures will be determined based on time-activity curves of the Fluciclovine PET scan.

The Fluciclovine time-activity curve of the primary tumor (time to peak, uptake intensity, and slope of washout) will be correlated with histopathologic tumor grading.

Parameters of textural tumor heterogeneity will be compared between Fluciclovine PET and FDG PET, using the open-access LIFEx software. The software allows for an automatic evaluation of more than 50 parameters for textural analyses and shows the result of the best parameters for tumor heterogeneity; however, no specific marker or measure of heterogeneity is be predefined in this process.

Nghi Nguyen

Associate Professor

Subjects with recently biopsy-proven malignancy of the cervix or uterus undergo an 18F fluciclovine PET scan on a hybrid PET/MRI scanner after they have completed a standard-of-care F-18 FDG PET/CT study.

18F fluciclovine: Each subject will receive one IV dose of 18F fluciclovine for PET scanning

18F fluciclovine PET: Each subject will undergo one 18F fluciclovine PET scan on a hybrid PET/MRI scanner

18F Fluciclovine PET Scan

Age, Categorical

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Nghi C. Nguyen, MD, PhD

SUV of standard-of-care FDG

SUV of research Fluciclovine

Lesion Metabolic Avidity

Only one subject measured, so unable to determine optimal time window

Optimal Imaging Window

Only one subject measured, so unable to determine correlation of time-activity-curve with histopathology.

Fluciclovine PET Time-activity Curve Correlation With Histopathologic Tumor Grading

Only one subject measured, so parameter output of software program would not be appropriate.

Textural Tumor Heterogeneity

18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus

An open-label, single dose, single arm, prospective, multicenter Phase 3 study to establish the diagnostic performance of 18F fluciclovine positron emission tomography (PET) in detecting recurrent brain metastases after radiation therapy

Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases

An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 3 Study to Establish the Diagnostic Performance of 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy

PPA (equivalent to sensitivity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.

NPA (equivalent to specificity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.

Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.

Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
18F-Fluciclovine PET-MRI in High-grade Glioma	NCT05553041	Glioma High Grade Glio... Glioma, Maligna... Glioma Intracra... Diffuse Glioma	18F-Fluciclovin...	1 Year - 21 Years	Children's Hospital of Philadelphia
Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)	NCT04410367	Brain Metastase...	18F fluciclovin...	18 Years -	Blue Earth Diagnostics
Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery	NCT04689048	Brain Metastase... Brain Metastase... Brain Cancer	18F fluciclovin...	18 Years -	Baptist Health South Florida
18F-Fluciclovine PET-MRI in High-grade Glioma	NCT05553041	Glioma High Grade Glio... Glioma, Maligna... Glioma Intracra... Diffuse Glioma	18F-Fluciclovin...	1 Year - 21 Years	Children's Hospital of Philadelphia
18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery	NCT06048094	Brain Metastase... Brain Metastase... Brain Cancer	18F fluciclovin...	18 Years -	Baptist Health South Florida
Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer.	NCT03423082	Cervical Cancer Uterine Cancer	18F fluciclovin... 18F fluciclovin...	18 Years -	University of Pittsburgh
Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)	NCT04410367	Brain Metastase...	18F fluciclovin...	18 Years -	Blue Earth Diagnostics
Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases	NCT04410133	Brain Metastase...	18F fluciclovin...	18 Years -	Blue Earth Diagnostics

Spots Global Cancer Trial Database for 18f fluciclovine