Personalized Translational Platform for Biomarker Discovery in Brain Tumors

• Sponsor: Marcelo F. Di Carli, MD, FACC (Other)
• Overall Status: Completed
• CT.gov ID: NCT01240161
• Collaborator: Society of Nuclear Medicine and Molecular Imaging (Other), General Electric (Industry)
• Enrollment: 37
• Locations: 2
• Duration (Months): 75
• Patients Per Site: 18.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

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

Study Design

• Study Type: Observational
• Actual Enrollment: 37 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Personalized Translational Platform for Biomarker Discovery in Brain Tumors
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Overall Survival [7 months]

2. Progression free Survival [7 months]

   MRI and clinical criteria

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California at San Diego	San Diego	California	United States	92093
2	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: Marie Kijewski, PhD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marcelo F. Di Carli, MD, FACC, Chief of Nuclear Medicine/PET, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT01240161
• Other Study ID Numbers: 2008P000554
• First Posted: Nov 15, 2010
• Last Update Posted: Aug 29, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by Marcelo F. Di Carli, MD, FACC, Chief of Nuclear Medicine/PET, Brigham and Women's Hospital: Glioblastoma multiforme; FLT; PET
• Additional relevant MeSH terms: Brain Neoplasms

Study Results

No Results Posted as of Aug 29, 2017