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

NCT02328300 | Withdrawn DMC

• 1 other identifier: LCCC1327
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Brain Lesions; Brain Metastasis; Brain Metastases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

FLT PET/MR 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.

Also known as: FLT PET/MRI

FLT PET/MR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

UNC Hospitals

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yueh Lee, MD/PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: December 31, 2014
• Study Start: May 7, 2014
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

US (1)