Chapel Hill, North Carolina 27599


Purpose:

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 summary:

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.


Criteria:

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)


NCT ID:

NCT02328300


Primary Contact:

Principal Investigator
Yueh Lee, MD/PhD
University of North Carolina, Chapel Hill

Soma Prum
Phone: 919-843-9245
Email: soma_prum@med.unc.edu


Backup Contact:

Email: kristine_baluyot@med.unc.edu
Kristine Baluyot
Phone: 919-843-5420


Location Contact:

Chapel Hill, North Carolina 27599
United States

Kristine Baluyot
Phone: 919-843-5420
Email: kristine_baluyot@med.unc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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