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

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ClinicalTrials.gov Identifier: NCT03930173
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Secondary Malignant Neoplasm of Brain and Cerebral Meninges Drug: 18F-fluciclovine Device: PET/CT of the brain Early Phase 1

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 Design
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Study Type : Interventional
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

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Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy of 18F-fluciclovine PET as measured by area under the ROC curve (AUC) [ Time Frame: 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 :
  1. 18F-fluciclovine uptake in lesions, compared to normal brain tissue. [ Time Frame: Up to 1 year from start of study ]
    18F-fluciclovine uptake in lesions will be reported in comparison to normal brain tissue.

  2. Sensitivity and specificity of 18F-fluciclovine PET [ Time Frame: Up to 1 year from start of study ]
    Sensitivity and specificity of 18F-fluciclovine PET diagnostic procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930173


Contacts
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Contact: Samuel T Chao 886-223-8100 CancerCenterResearch@ccf.org

Locations
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United States, Ohio
Cleveland Clinic, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Samuel Chao    216-444-5571    chaos@ccf.org   
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Samuel Chao The Cleveland Clinic
More Information
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03930173     History of Changes
Other Study ID Numbers: CASE2319
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Brain Neoplasms
Necrosis
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
 Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases