Personalized Translational Platform for Biomarker Discovery in Brain Tumors

Marcelo F. Di Carli, MD, FACC

Status: Completed

Conditions: High Grade Glioma

Treatments: Drug: FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CT

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01240161

2008P000554

Details and patient eligibility

About

The central hypothesis for this proposal is that multimodal (clinical, imaging, tissue) biomarkers will better predict early brain tumor response to treatments and will be more reliable prognostic markers in patients with malignant brain tumors.

Enrollment: 37 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed or suspected high grade glioma ≥ 1cm in diameter on postoperative anatomic imaging (contrast MRI), prior to initiation of chemoXRT
• Anticipated survival ≥6 months
• Able to give informed consent
• Capable of undergoing MRI and PET scans without the need for sedation or general anesthesia
• Male or Female

Exclusion criteria

• Prior radiation therapy and chemotherapy to the brain
• Active intracranial infection or nonglial brain mass.
• Recent large intracranial hemorrhage (<1 month)
• Expected survival <6 months
• Pregnant or nursing
• Renal failure
• Lives far from BWH and/or is unwilling/ unable to return for scheduled imaging visits.

Trial design

37 participants in 1 patient group

Patients with high grade gliomas

Description:

All subjects will have radiographically suspected or surgically proven de novo high grade gliomas. There are no control patients.

Treatment:

Drug: FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CT