NCT03930173

18F-Fluciclovine PET to Distinguish Tumor Progression From Radiation Necrosis

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Secondary Malignant Neoplasm of Brain and Cerebral Meninges

Interventions

Type	Name	Description
DRUG	18F-fluciclovine	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

Timeline

• Start date: 2019-07-02
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2019-04-29
• Last updated: 2021-05-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study