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

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02328300
• Other study ID #: LCCC1327
• Status: Withdrawn
• Start date: May 7, 2014
• Est. completion date: July 31, 2018

Study information

• Verified date: November 2018
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain Lesions
• Brain Metastases
• Brain Metastasis
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
United States	University of North Carolina-Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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