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Personalized Translational Platform for Biomarker Discovery in Brain Tumors

Personalized Translational Platform for Biomarker Discovery in Brain Tumors

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01240161
Enrollment
37
Registered
2010-11-15
Start date
2009-12-31
Completion date
2016-03-31
Last updated
2017-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Grade Glioma

Keywords

Glioblastoma multiforme, FLT, PET

Brief summary

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.

Interventions

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

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

Sponsors

Society of Nuclear Medicine and Molecular Imaging
CollaboratorUNKNOWN
General Electric
CollaboratorINDUSTRY
Marcelo F. Di Carli, MD, FACC
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival7 months
Progression free Survival7 monthsMRI and clinical criteria

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026