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

Primary Purpose

Secondary Malignant Neoplasm of Brain and Cerebral Meninges

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

18F-fluciclovine

PET/CT of the brain

About this trial

This is an interventional diagnostic trial for Secondary Malignant Neoplasm of Brain and Cerebral Meninges

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-fluciclovine PET/CT of the brain

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

18F-fluciclovine uptake in lesions will be reported in comparison to normal brain tissue.

Sensitivity and specificity of 18F-fluciclovine PET

Sensitivity and specificity of 18F-fluciclovine PET diagnostic procedure

Full Information

NCT ID

NCT03930173

First Posted

April 25, 2019

Last Updated

May 3, 2021

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT03930173

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

July 2, 2019 (Actual)

Primary Completion Date

March 1, 2021 (Actual)

Study Completion Date

March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Secondary Malignant Neoplasm of Brain and Cerebral Meninges

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

18F-fluciclovine PET/CT of the brain

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

18F-fluciclovine

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

PET/CT of the brain

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

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

Description

18F-fluciclovine uptake in lesions will be reported in comparison to normal brain tissue.

Time Frame

Up to 1 year from start of study

Title

Sensitivity and specificity of 18F-fluciclovine PET

Description

Sensitivity and specificity of 18F-fluciclovine PET diagnostic procedure

Time Frame

Up to 1 year from start of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samuel T Chao, MD

Organizational Affiliation

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34081125

Citation

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.

Results Reference

derived

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

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