An interventional study of MRI perfusion and PET/CT scans in Brain Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Diagnostic
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 148 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The 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.
Diagnostic Test: MRI perfusion and PET/CT scans
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.
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.
Time frame: 2 years
Median Time Between Radiation Therapy and Detection of Indeterminate Lesion
Median time between Radiation Therapy and detection of indeterminate lesion
Time frame: up to 99 months
| Milestone | Pts With a Brain Tumor |
|---|---|
| Started | 148 |
| Completed | 141 |
| Not completed | 7 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Not treated | 4 |
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.
| Participants | Pts With a Brain Tumor |
|---|---|
| Participants who received PET/CT and MRI perfusion studies | 53 |
| Participants who did not receive PET/CT and MRI perfusion studies | 95 |
Median time between Radiation Therapy and detection of indeterminate lesion
| months | Pts With a Brain Tumor |
|---|---|
| Median Time Between Radiation Therapy and Detection of Indeterminate Lesion | 9 (1 to 99) |
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pts With a Brain Tumor | 18/148 (12.2%) | 6/148 (4.1%) | 0/148 (0%) |
| Event | Pts With a Brain Tumor |
|---|---|
| Death NOSGeneral disorders | 5/148 |
| SeizureNervous system disorders | 1/148 |
| Age, Continuous(years) | Pts With a Brain Tumor |
|---|---|
| Median | 56 (20 to 91) |
| Sex: Female, Male(Participants) | Pts With a Brain Tumor |
|---|---|
| Female | 79 |
| Male | 69 |
| Ethnicity (NIH/OMB)(Participants) | Pts With a Brain Tumor |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 74 |
| Unknown or Not Reported | 69 |
| Race (NIH/OMB)(Participants) | Pts With a Brain Tumor |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 8 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 8 |
| White | 124 |
| More than one race | 0 |
| Unknown or Not Reported | 7 |
| Region of Enrollment(Participants) | Pts With a Brain Tumor |
|---|---|
| United States | 148 |
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Memorial Sloan Kettering Cancer Center