Personalized Translational Platform for Biomarker Discovery in Brain Tumors

NCT ID: NCT01240161

Last Updated: 2017-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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High Grade Glioma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with high grade gliomas

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

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Society of Nuclear Medicine and Molecular Imaging

UNKNOWN

Sponsor Role collaborator

General Electric

INDUSTRY

Sponsor Role collaborator

Marcelo F. Di Carli, MD, FACC

OTHER

Sponsor Role lead

Responsible Party

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Marcelo F. Di Carli, MD, FACC

Chief of Nuclear Medicine/PET

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marie Kijewski, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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University of California at San Diego

San Diego, California, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2008P000554

Identifier Type: -

Identifier Source: org_study_id

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