A Comparison of MRI Perfusion and FDG PET/CT to Distinguish Between Radiation Injury and Tumor Progression

Status:	Recruiting
Conditions:	Cancer, Other Indications, Brain Cancer, Hospital
Therapuetic Areas:	Oncology, Other
Healthy:	No
Age Range:	18 - Any
Updated:	8/17/2018
Start Date:	May 2012
End Date:	May 2019
Contact:	Robert Young, MD
Phone:	212-639-8196

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

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

We found this trial at

sites

Memorial Sloan Kettering Cancer Center

1275 York Ave
New York, New York 10021

(212) 639-2000