An observational study in Brain Lesions, Brain Metastasis and Brain Metastases, sponsored by UNC Lineberger Comprehensive Cancer Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Observational
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).
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
Browse Neoplasm Metastasis studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
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UNC Hospitals
Exclusion Criteria:
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.
Drug: FLT PET/MR
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.
Also known as: FLT PET/MRI
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
This study is withdrawn, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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UNC Lineberger Comprehensive Cancer Center