CompletedNCT03930173Updated May 5, 2021

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

An Early Phase 1 interventional study of 18F-fluciclovine and PET/CT of the brain in Secondary Malignant Neoplasm of Brain and Cerebral Meninges, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-05.

Sponsored by Case Comprehensive Cancer Center · Early Phase 1, Interventional, and Diagnostic

From the registry’s dates

Primary completion was Mar 2021, 5 years 7 months ago, and no results have been posted to the registry.

Phase: Early Phase 1
Study type: Interventional
Enrollment: 18
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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 studied

Secondary Malignant Neoplasm of Brain and Cerebral Meninges

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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 18 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Early Phase 1
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 18 participants (actual)

Study arms

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.
Drug: 18F-fluciclovine · Device: PET/CT of the brain

Interventions

Drug18F-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.
DevicePET/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

What researchers measure

Primary outcomes

Accuracy of 18F-fluciclovine PET as measured by area under the ROC curve (AUC)
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.
Time frame: Up to 1 year from start of study

Secondary outcomes

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

Study locations

1 site

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio 44195, United States

References and documents

Publications

Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available. PubMed 34081125 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03930173
Lead sponsor: Case Comprehensive Cancer Center
Responsible party: Sponsor
First posted: Apr 29, 2019
Start date: Jul 2, 2019
Primary completion: Mar 1, 2021
Completion: Mar 1, 2021
Last update: May 5, 2021

Study contacts

Samuel T Chao, MD

principal investigator · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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