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

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. Identifier: NCT02328300
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : October 4, 2017
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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).

Condition or disease Intervention/treatment
Brain Lesions Brain Metastasis Brain Metastases 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
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FLT PET/MR for Evaluation of Pseudoprogression in Patients With Brain Lesions
Actual Study Start Date : May 7, 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Group/Cohort Intervention/treatment

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.

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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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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

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)

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 identifier (NCT number): NCT02328300

Contact: Soma Prum 919-843-9245
Contact: Kristine Baluyot 919-843-5420

United States, North Carolina
University of North Carolina-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kristine Baluyot    919-843-5420   
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
Principal Investigator: Yueh Lee, MD/PhD University of North Carolina, Chapel Hill

Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT02328300     History of Changes
Other Study ID Numbers: LCCC1327
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017

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