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

NCT03930173 | Completed Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: CASE2319
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Malignant Neoplasm of Brain and Cerebral Meninges

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 year from start of study

Secondary Outcomes (2)

• 18F-fluciclovine uptake in lesions, compared to normal brain tissue.

  Up to 1 year from start of study

• Sensitivity and specificity of 18F-fluciclovine PET

  Up to 1 year from start of study

Study Arms (1)

18F-fluciclovine PET/CT of the brain

EXPERIMENTAL

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

18F-fluciclovine DRUG

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.

18F-fluciclovine PET/CT of the brain

PET/CT of the brain DEVICE

Each subject will undergo 18F-fluciclovine PET/CT of the brain which will be performed ≤ 30 days from equivocal MRI brain

18F-fluciclovine PET/CT of the brain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 34081125 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Samuel T Chao, MD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 29, 2019
• Study Start: July 2, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)