Personalized Translational Platform for Biomarker Discovery in Brain Tumors

August 28, 2017 updated by: Marcelo F. Di Carli, MD, FACC
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92093
        • University of California at San Diego
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 7 months
7 months
Progression free Survival
Time Frame: 7 months
MRI and clinical criteria
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marcelo F. Di Carli, MD, FACC

Collaborators

General Electric
Society of Nuclear Medicine and Molecular Imaging

Investigators

  • Principal Investigator: Marie Kijewski, PhD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 10, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (Estimate)

November 15, 2010

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008P000554

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on High Grade Glioma

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe