Personalized Translational Platform for Biomarker Discovery in Brain Tumors

This study has been completed.
Sponsor:
Collaborators:
Society of Nuclear Medicine and Molecular Imaging
General Electric
Information provided by (Responsible Party):
Marcelo F. Di Carli, MD, FACC, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01240161
First received: November 10, 2010
Last updated: August 16, 2016
Last verified: August 2016
  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.

Condition Intervention
High Grade Glioma
Drug: FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Personalized Translational Platform for Biomarker Discovery in Brain Tumors

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Progression free Survival [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    MRI and clinical criteria


Enrollment: 37
Study Start Date: December 2009
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with high grade gliomas
All subjects will have radiographically suspected or surgically proven de novo high grade gliomas. There are no control patients.
Drug: FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CT
Each patient will have 0-3 or more FLT-PET brain scans.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to BWH/DFCI emergency department (ED), inpatient, or neurology/ neurosurgery/ radiation oncology clinics with newly diagnosed brain masses (suspected high grade gliomas) will be consented and enrolled in this study after adequate explanation of the risks and benefits of the study.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240161

Locations
United States, California
University of California at San Diego
San Diego, California, United States, 92093
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Marcelo F. Di Carli, MD, FACC
Society of Nuclear Medicine and Molecular Imaging
General Electric
Investigators
Principal Investigator: Laura L Horky, MD, PhD Brigham and Women's Hospital
  More Information

Responsible Party: Marcelo F. Di Carli, MD, FACC, Chief of Nuclear Medicine/PET, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01240161     History of Changes
Other Study ID Numbers: 2008P000554 
Study First Received: November 10, 2010
Last Updated: August 16, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Glioblastoma multiforme
FLT
PET

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2016