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Personalized Translational Platform for Biomarker Discovery in Brain Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01240161
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Marcelo F. Di Carli, MD, FACC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marie Kijewski, PhD
Principal Investigator Affiliation Brigham and Women's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

High Grade Glioma
Arms & Interventions

Arms

: Patients with high grade gliomas

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

Interventions

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

Each patient will have 0-3 or more FLT-PET brain scans.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California at San Diego, San Diego, California

Status

Address

University of California at San Diego

San Diego, California, 92093

Brigham and Women's Hospital, Boston, Massachusetts

Status

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115