We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified October 2017 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02328300
First Posted: December 31, 2014
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
  Purpose
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).

Condition Intervention
Brain Lesions Brain Metastasis Brain Metastases Drug: FLT PET/MR

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: FLT PET/MR for Evaluation of Pseudoprogression in Patients With Brain Lesions

Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Sensitivity and specificity of FLT-PET-MRI in distinguishing between recurrence and radiation necrosis, with surgical biopsy as gold standard [ Time Frame: 1 week post-surgical biopsy ]

Estimated Enrollment: 15
Actual Study Start Date: May 7, 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: FLT PET/MRI

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
UNC Hospitals
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328300


Contacts
Contact: Soma Prum 919-843-9245 soma_prum@med.unc.edu
Contact: Kristine Baluyot 919-843-5420 kristine_baluyot@med.unc.edu

Locations
United States, North Carolina
University of North Carolina-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kristine Baluyot    919-843-5420    kristine_baluyot@med.unc.edu   
Sub-Investigator: Carey Anders, MD         
Sub-Investigator: Matthew Ewend, MD         
Sub-Investigator: Timothy Zagar, MD         
Sub-Investigator: Terence Wong, MD/PhD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Yueh Lee, MD/PhD University of North Carolina, Chapel Hill
  More Information

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02328300     History of Changes
Other Study ID Numbers: LCCC1327
First Submitted: August 29, 2014
First Posted: December 31, 2014
Last Update Posted: October 4, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Neoplasm Metastasis
Brain Neoplasms
Brain Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases