NCT01240161CompletedNot Applicable
Personalized Translational Platform for Biomarker Discovery in Brain Tumors
Marcelo F. Di Carli, MD, FACC2 sites in 1 country37 target enrollmentStarted: December 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Overall Survival
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Overall Survival
Time Frame: 7 months
Progression free Survival
Time Frame: 7 months
MRI and clinical criteria
Secondary Outcomes
No secondary outcomes reported
Investigators
Marcelo F. Di Carli, MD, FACC
Chief of Nuclear Medicine/PET
Brigham and Women's Hospital
Study Sites (2)
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