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

Early Phase 1

Completed

• Conditions: Secondary Malignant Neoplasm of Brain and Cerebral Meninges
• Interventions: Drug: 18F-fluciclovine; Device: PET/CT of the brain

• Registration Number: NCT03930173
• Lead Sponsor: Case Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-29
• Study Start: 2019-07-02
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Subjects must have a confirmed diagnosis of brain metastases.
• Subjects must have received prior intracranial SRS at least once for brain metastases. Prior WBRT is allowed.
• Subjects must have had a clinical tumor protocol MRI of the brain including a DSC-MR perfusion sequence, which is equivocal for radiation necrosis versus tumor progression within 30 days of treatment scan. "Equivocal" will be defined as being inconclusive for radiation necrosis versus tumor progression as determined by the study neuroradiologist.
• Physician assessed life expectancy of ≥ 6 months.
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.
• For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required.

Exclusion Criteria

• Subjects who have experienced a prior anaphylaxis reaction to 18Ffluciclovine are not eligible.
• Females pregnant at the expected time of 18F-fluciclovine administration are not eligible due to potential harm to the fetus from exposure to radiation. Women who could be pregnant require a negative pregnancy test to be eligible.
• Women who are breast feeding at the expected time of 18F-fluciclovine administration are not eligible due to potential harm to the infant from exposure to radiation.
• Subjects contraindicated for MRI.
• Subjects unable or unwilling to comply with study requirements are not eligible.
• Major medical illness or psychiatric impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent.
• Brain metastases from primary lymphoma, germ cell tumor, or small cell carcinoma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-fluciclovine PET/CT of the brain	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.
18F-fluciclovine PET/CT of the brain	18F-fluciclovine	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.

Primary Outcome Measures

Name	Time	Method
Accuracy of 18F-fluciclovine PET as measured by area under the ROC curve (AUC)	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.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of 18F-fluciclovine PET	Up to 1 year from start of study	Sensitivity and specificity of 18F-fluciclovine PET diagnostic procedure
18F-fluciclovine uptake in lesions, compared to normal brain tissue.	Up to 1 year from start of study	18F-fluciclovine uptake in lesions will be reported in comparison to normal brain tissue.

Trial Locations

Locations (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States