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Clinical Trials/NCT01240161
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

Sponsor
Marcelo F. Di Carli, MD, FACC
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Marcelo F. Di Carli, MD, FACC

Chief of Nuclear Medicine/PET

Brigham and Women's Hospital

Study Sites (2)

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