18F-Fluciclovine PET to Distinguish Tumor Progression From Radiation Necrosis
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|ClinicalTrials.gov Identifier: NCT03930173|
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : June 14, 2019
The purpose of this study is to evaluate whether 18F-fluciclovine PET/CT of the brain, is able to distinguish radiation necrosis from tumor progression in cases where MRI is inconclusive.
18F-fluciclovine is an FDA approved radioactive diagnostic agent and is injected into the participant and then taken up by cancer cells, which can then be visualized with a PET/CT scan. 18F-fluciclovine is FDA approved for the detection of recurrent prostate cancer, but is still investigational for the purposes of this study.
|Condition or disease||Intervention/treatment||Phase|
|Secondary Malignant Neoplasm of Brain and Cerebral Meninges||Drug: 18F-fluciclovine Device: PET/CT of the brain||Early Phase 1|
The primary objective of this study is to estimate the accuracy of 18F-fluciclovine PET in distinguishing radiation necrosis from tumor progression. Accuracy will be assessed via receiver operating characteristic curve analysis, as well as by calculating sensitivity and specificity.
Secondary objectives of this study are to assess which factors may influence accuracy of 18Ffluciclovine PET in distinguishing radiation necrosis from tumor progression and to compare the accuracy of each of the qualitative and quantitative metrics.
|Study Type :||Interventional|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Pilot to Evaluate the Diagnostic Assessment of 18F-Fluciclovine Positron Emission Tomography to Distinguish Tumor Progression From Radiation Necrosis Following Stereotactic Radiosurgery for Brain Metastases|
|Actual Study Start Date :||June 10, 2019|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||October 1, 2021|
Experimental: 18F-fluciclovine PET/CT of the brain
Arm includes participants with a known diagnosis of brain metastases who have undergone prior intracranial SRS and whose MRI brain scan is equivocal for radiation necrosis versus tumor progression.
Participants will undergo 18F-fluciclovine PET/CT of the brain. Qualitative and quantitative metrics will be documented at the time of image acquisition. Qualitative image assessment will be performed independently by 3 separate physicians.
A single dose of 18F-fluciclovine will be administered intravenously for PET/CT imaging. The standard 10 mCi dose will be used for this study.
Device: PET/CT of the brain
Each subject will undergo 18F-fluciclovine PET/CT of the brain which will be performed ≤ 30 days from equivocal MRI brain
- Accuracy of 18F-fluciclovine PET as measured by area under the ROC curve (AUC) [ Time Frame: Up to 1 year from start of study ]The accuracy of 18F-fluciclovine PET in distinguishing radiation necrosis from tumor progression will be reported. Accuracy will be assessed via receiver operating characteristic curve analysis.
- 18F-fluciclovine uptake in lesions, compared to normal brain tissue. [ Time Frame: Up to 1 year from start of study ]18F-fluciclovine uptake in lesions will be reported in comparison to normal brain tissue.
- Sensitivity and specificity of 18F-fluciclovine PET [ Time Frame: Up to 1 year from start of study ]Sensitivity and specificity of 18F-fluciclovine PET diagnostic procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930173
|Contact: Samuel T Chao||886-223-8100||CancerCenterResearch@ccf.org|
|United States, Ohio|
|Cleveland Clinic, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Samuel Chao 216-444-5571 firstname.lastname@example.org|
|Principal Investigator:||Samuel Chao||The Cleveland Clinic|