FLT PET/MR for Evaluation of Pseudoprogression in Patients With Brain Lesions

• Status: Withdrawn
• Trial end date: 2018-07-31
• Target enrollment: 0
• Participant gender: All

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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)