- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02328300
FLT PET/MR for Evaluation of Pseudoprogression in Patients With Brain Lesions
November 9, 2018 updated by: UNC Lineberger Comprehensive Cancer Center
This is a single arm, single center study of 15 patients with brain lesions being treated at UNC Hospitals.
Subjects will undergo one (1) FLT-PET-MRI scan before their scheduled surgical biopsy of their brain lesion(s).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Identifying imaging biomarkers of metastatic brain tumor treatment response could allow early modification of treatment by determination of tumor progression vs. treatment related effects (pseudo-progression, radiation necrosis).
Earlier treatment response assessment could reduce cost, improve clinical trial efficiency and allow better assessment of prognosis.
The development of PET/MRI offers the possibility of combining the functional imaging of PET with the exquisite soft tissue contrast and physiologic imaging capabilities of MRI.
Combining FLT-PET imaging with MRI may allow better evaluation of new and unclear lesions in brain metastatic disease.
The goal of this study is to explore FLT-PET imaging combined with dynamic MR imaging techniques for the identification of tumor response markers in metastatic brain tumors.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina-Chapel Hill
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
UNC Hospitals
Description
Inclusion Criteria:
- Known brain lesion in central nervous system (CNS) scheduled to have surgical biopsy of the lesion, identified by the UNC Brain Tumor Board as having clinical question of radiation necrosis vs. recurrence
- At least one measurable lesion greater than 1 cm in diameter
- ≥ 18 years of age
- Study-specific informed consent reviewed and signed
Exclusion Criteria:
- Pregnant, nursing, or planning to become pregnant within 30 days of anticipated PET-MRI scan
- Condition that makes MRI unsafe (e.g., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, metal aneurysm clips, metal halo devices)
- Inability to tolerate MRI (e.g., unable to lie flat for > 1 hour, severe claustrophobia)
- Allergy to MRI contrast agent (Magnevist, Multihance, Ablavar, Dotarem, Eovist, Gadavist)
- Known allergy to fluorothymidine
- Study participation would cause significant delay (> 2 weeks) in scheduled standard of care therapy
- Creatinine clearance < 60 ml/min, as estimated by the Cockcroft-Gault formula
- Body Mass Index (BMI) > 35
- Poorly controlled diabetes mellitus (fasting blood glucose > 200 mg/dl)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
FLT PET/MR
All participants will have known brain lesion in the central nervous system (CNS) scheduled to have surgical biopsy of the lesion, identified by the UNC Brain Tumor Board and will have the clinical question of radiation necrosis vs. recurrence. All participants will receive a FLT PET/MR scan. |
Each participant will be injected with FLT, a common PET radiotracer for brain tumors and lesions, and then will complete one (1) PET/MR scan.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensitivity and specificity of FLT-PET-MRI in distinguishing between recurrence and radiation necrosis, with surgical biopsy as gold standard
Time Frame: 1 week post-surgical biopsy
|
1 week post-surgical biopsy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yueh Lee, MD/PhD, University of North Carolina, Chapel Hill
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 7, 2014
Primary Completion (Actual)
July 31, 2018
Study Completion (Actual)
July 31, 2018
Study Registration Dates
First Submitted
August 29, 2014
First Submitted That Met QC Criteria
December 29, 2014
First Posted (Estimate)
December 31, 2014
Study Record Updates
Last Update Posted (Actual)
November 14, 2018
Last Update Submitted That Met QC Criteria
November 9, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC1327
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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