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

NCT ID: NCT02328300

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-07
• Study Completion Date: 2018-07-31

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.

Conditions

Brain Lesions; Brain Metastasis; Brain Metastases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

FLT PET/MR

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

FLT PET/MRI

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yueh Lee, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

LCCC1327

Identifier Type: -

Identifier Source: org_study_id