Clinical trial NCT02328300: FLT PET/MR for Evaluation of Pseudoprogression in Patients With Brain Lesions
Official title: FLT PET/MR for Evaluation of Pseudoprogression in Patients With Brain Lesions
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Brain Lesions
Brain Metastasis
Brain Metastases
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UNC Hospitals

Brief summary: 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).

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.

Eligibility 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)

Primary outcomes:
measure: Sensitivity and specificity of FLT-PET-MRI in distinguishing between recurrence and radiation necrosis, with surgical biopsy as gold standard
timeFrame: 1 week post-surgical biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina-Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Yueh Lee, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: