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

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 Overview

• Status: Withdrawn
• Conditions: Brain Metastasis; Brain Metastases; Brain Lesions
• Intervention / Treatment: Drug: FLT PET/MR

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina-Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

UNC Hospitals

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; Other Names: FLT PET/MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of FLT-PET-MRI in distinguishing between recurrence and radiation necrosis, with surgical biopsy as gold standard	1 week post-surgical biopsy

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Yueh Lee, MD/PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2014
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: August 29, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: LCCC1327