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Development of MRF for Characterization of Brain Tumors After Radiotherapy
The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging (MRI) technique, named Magnetic Resonance Fingerprinting (or MRF), to achieve high-quality images within a short scan time of 5 min for viewing the entire brain. This is an advanced quantitative assessment of brain tissues. This method is being applied with IVIM MRI to be able to tell the difference between a brain with radiation necrosis and a brain with tumor recurrence. Participants will consist of individuals who have received radiation therapy in the past and were diagnosed with radiation necrosis, individuals with recurrent tumors, and healthy individuals who have no brain diseases and have not had radiation treatment to the brain. Participants will undergo an MRI scan at a one-time research study visit; no extra tests or procedures will be required for this research study. The primary objectives of this study are: * To demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage. * To apply the developed quantitative approach in combination with IVIM MRI for differentiation of tumor recurrence and radiation necrosis.
Conditions:
🦠 Brain Tumor 🦠 Brain Necrosis 🦠 Brain Metastases
🗓️ Study Start (Actual) 1 September 2024
🗓️ Primary Completion (Estimated) 30 June 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Cleveland, Ohio, United States

📋 Eligibility Criteria

Description

  • Inclusion Criteria for Healthy Participants:
  • * No history of cerebrovascular disease.
  • * No cognitive impairments.
  • * Able to provide informed consent.
  • Inclusion Criteria for Participants with Brain Tumors:
  • * Biopsy-proven cases of developed recurrent tumor or radiation necrosis,
  • OR:
  • * a. PET identified with developed recurrent tumor or radiation necrosis. OR
  • * b. Highly suspicious case with developed recurrent tumor or radiation necrosis confirmed by tumor board, attending physician or surgeon.
  • * ECOG performance status 0-2.
  • * Life expectancy \> 6 months.
  • * Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.

Exclusion Criteria:

  • * Pregnant women OR lactating women
  • * Participants with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
  • * Participants who cannot go into the MRI scanner due to metal implants and other medical conditions.
  • * The presence of an implanted medical device that is not MRI-compatible, including, but not limited to: pacemaker, defibrillator.
  • * Participants with contraindications for MRI due to embedded foreign metallic objects such as bullets, shrapnel, metalwork fragments, or other metallic material.
  • * Known history of severe claustrophobia.
  • * Participants unable to lay still in the scanner for 30 minutes at a time.
Ages Eligible for Study: 21 Years to 60 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 October 2023
  • First Submitted that Met QC Criteria 20 October 2023
  • First Posted 25 October 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 July 2024
  • Last Update Posted 30 July 2024
  • Last Verified July 2024