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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

Tracking Information
First Submitted Date  ICMJE April 25, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date June 14, 2019
Actual Study Start Date  ICMJE June 10, 2019
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03930173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 18F-Fluciclovine PET to Distinguish Tumor Progression From Radiation Necrosis
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Secondary Malignant Neoplasm of Brain and Cerebral Meninges
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.

Interventions:
  • Drug: 18F-fluciclovine
  • Device: PET/CT of the brain
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2019)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Samuel T Chao 886-223-8100 CancerCenterResearch@ccf.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03930173
Other Study ID Numbers  ICMJE CASE2319
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Case Comprehensive Cancer Center
Study Sponsor  ICMJE Case Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samuel Chao The Cleveland Clinic
PRS Account Case Comprehensive Cancer Center
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP