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OpenTrials
Completed

NCT Number: NCT01240161

Personalized Translational Platform for Biomarker Discovery in Brain Tumors

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.

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Key information

Conditions

High Grade Glioma Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California at San Diego, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Overall Survival

    Time frame: 7 months

  2. Progression free Survival

    Time frame: 7 months

    MRI and clinical criteria

Sponsors and collaborators

Lead sponsor

Marcelo F. Di Carli, MD, FACC

Other

Collaborators

  • General Electric
  • Society of Nuclear Medicine and Molecular Imaging

Registry information

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Nov 15, 2010
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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