Enhancing Brain Lesions After Radiation Therapy: A Comparison of MRI Perfusion and FDG PET/CT to Distinguish Between Radiation Injury and Tumor Progression

Status: Completed
Location: See all (6) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge
Memorial Sloan Kettering Monmouth
Middletown
Memorial Sloan Kettering Bergen
Montvale
New York
Memorial Sloan Kettering Commack
Commack
Memorial Sloan Kettering Westchester
Harrison
Memorial Sloan Kettering Cancer Center
New York
Time Frame
Start Date: 2012-05
Completion Date: 2023-12-29
Participants
Target number of participants: 147
Treatments
Experimental: Pts with a brain tumor
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.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov