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A Study of [¹⁸F]-ML-10 as a PET Imaging Radiotracer for the Early Detection of Response of Brain Metastases of Solid Tumors to Radiation Therapy

[Protocol 08-116]

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Full Title :

AN OPEN-LABEL, MULTI-CENTER STUDY, TO EVALUATE THE EFFICACY AND SAFETY OF 18F-ML-10, AS A PET IMAGING RADIOTRACER, IN EARLY DETECTION OF RESPONSE OF BRAIN METASTASES OF SOLID TUMORS TO RADIATION THERAPY

Purpose :

There are currently no markers available to show the response of brain cancer cells to radiotherapy during the early stages of treatment. The purpose of this clinical study is to determine if a new substance called [¹⁸F]-ML-10 can locate dying cancer cells in response to single-fraction high-dose radiation therapy in patients with brain metastases from solid tumors.

This study will be performed using a PET/CT scanner, an imaging tool used to generate a high-quality picture of what is taking place inside the body.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have a solid tumor that has metastasized to the brain. Patients may have up to four metastatic brain lesions.
• Patients must be able to tolerate lying still during the PET/CT imaging session, which may last for up to 4 hours with intermediate breaks.
• Patients must not be confined to a bed or chair for more than half of their normal waking hours.
• Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Kathryn Beal at 212-639-5159.