Personalized Translational Platform for Biomarker Discovery in Brain Tumors

High Grade Glioma Clinical Trial

Official title:

Personalized Translational Platform for Biomarker Discovery in Brain Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240161
• Other study ID #: 2008P000554
• Status: Completed
• Phase: N/A
• First received: November 10, 2010
• Last updated: August 28, 2017
• Start date: December 2009
• Est. completion date: March 2016

Study information

• Verified date: August 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• High Grade Glioma

Intervention

Drug:
• FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CT
Each patient will have 0-3 or more FLT-PET brain scans.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of California at San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Marcelo F. Di Carli, MD, FACC	General Electric, Society of Nuclear Medicine and Molecular Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		7 months
Primary	Progression free Survival	MRI and clinical criteria	7 months