A Comparison of MRI Perfusion and FDG PET/CT to Distinguish Between Radiation Injury and Tumor Progression
Enhancing Brain Lesions After Radiation Therapy: A Comparison of MRI Perfusion and FDG PET/CT to Distinguish Between Radiation Injury and Tumor Progression
1 other identifier
interventional
148
1 country
6
Brief Summary
This study will examine if MRI perfusion and PET/CT can tell growing tumor and radiation injury apart. MRI perfusion looks at the blood vessels in the tumor. PET/CT looks if the tumor cells are actively growing. The investigators will do these two tests and see which one is better. Patients will remain on study until the completion of either the MRI perfusion or PET/CT that are within 12 weeks of each other. After one of these scans, the patient will have no active interventions and will be off study. Optional: Restriction Spectrum Imaging (RSI) Sequence RSI sequence is an advanced way of looking at your brain. The scan allows doctors to see how water is moving within brain tumors or within brain cells. The extra sequence takes additional 4-5 minutes in the scanner. The RSI sequence is optional. The patient will only be asked to participate if the doctor believes that it will be helpful. Off study: Patients will remain on study until the completion of either the MRI perfusion or PET/CT that are within 12 weeks of each other. After one of these scans, the patient will have no active interventions and will be off study. Patients will obtain a standard of care brain MRI scan about every 2-3 months. These MRI scans will be used to track disease progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2012
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2023
CompletedResults Posted
Study results publicly available
April 8, 2025
CompletedApril 8, 2025
February 1, 2025
11.7 years
May 21, 2012
December 27, 2024
March 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Received PET/CT and MRI Perfusion Studies
To assess the utility of PET/CT and MRI perfusion studies in predicting whether worsening enhancing brain lesions seen after radiation therapy represent radiation injury or tumor progression. This study will examine the role of these two imaging techniques in predicting diagnosis and treatment planning.
2 years
Secondary Outcomes (1)
Median Time Between Radiation Therapy and Detection of Indeterminate Lesion
up to 99 months
Study Arms (1)
Pts with a brain tumor
EXPERIMENTALThe study will prospectively enroll patients who have increasing size and/or enhancement of brain lesion(s) after brain radiation therapy for a neoplasm (either primary or metastatic), where. it is unclear if a lesion represents radiation injury or progressive tumor. At the discretion of PI the RSI sequence may be repeated at SOC FDG or other radiotracer imaging carried out while the patient is still on study, if deemed clinically necessary.
Interventions
The MRI perfusion and PET/CT scans will be obtained within 12 weeks of each other. These scans are part of the standard of care for patients with brain tumors and uncertain tumor response or progression after treatment. Although every effort will be made to perform both MRI perfusion and PET/CT on the same day or during the same week, some patients may experience longer intervals between scans due to scheduling conflicts. The disease in question (radiation injury vs. tumor progression) may change slightly during this interval (e.g., the lesion may grow or shrink slightly), but no large changes are expected between the two scans. The patients may continue existing treatments in the interval between scans (e.g., steroids, chemotherapy), but the two scans must be performed before any change or new treatment occurs. Fusion images of MRI and PET/CT will not be reviewed by the neuroradiologist interpreting the MRI perfusion nor the nuclear medicine radiologist interpreting the PET/CT.
Eligibility Criteria
You may qualify if:
- Pathological or clinical/radiological diagnosis of aneoplasm , either primary (e.g., malignant glioma) or secondary (metastasis from systemic malignancy) with a history of brain radiation therapy
- Completed fractionated radiation therapy (to 60 Gy for high grade gliomas) or stereotactic radiosurgery or hypofractionated radiation therapy (e.g. for brain metastases, anaplastic meningiomas), without or with concurrent chemotherapy
- New or increased enhancing brain lesion(s) OR nonenhancing brain lesion(s) if receiving anti-angiogenic therapy, which is considered indeterminate for tumor progression vs. radiation injury by the neuroradiologist or clinician
- Patient and/or guardian is able to provide written informed consent prior to study registration
- Age ≥ 18 years old
You may not qualify if:
- Claustrophobia
- Known allergic reaction to Gd-DTPA
- Any contraindication to gadolinium intravenous contrast as per standard Department of Radiology contrast guidelines
- Any contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).
- Pregnant or nursing female
- Unable to cooperate for MRI and/or PET/CT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Robert Young, MD
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Young, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2012
First Posted
May 23, 2012
Study Start
May 1, 2012
Primary Completion
December 29, 2023
Study Completion
December 29, 2023
Last Updated
April 8, 2025
Results First Posted
April 8, 2025
Record last verified: 2025-02