Personalized Translational Platform for Biomarker Discovery in Brain Tumors
This study is currently recruiting participants.
Verified December 2012 by Brigham and Women's Hospital
Sponsor:
Brigham and Women's Hospital
Collaborators:
Society of Nuclear Medicine and Molecular Imaging
General Electric
Information provided by (Responsible Party):
Laura L. Horky, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01240161
First received: November 10, 2010
Last updated: December 20, 2012
Last verified: December 2012
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Purpose
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 | Intervention |
|---|---|
|
High Grade Glioma |
Drug: FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CT |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Personalized Translational Platform for Biomarker Discovery in Brain Tumors |
Resource links provided by NLM:
Further study details as provided by Brigham and Women's Hospital:
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240161
Contacts
| Contact: Laura L Horky, MD, PhD | 617-732-8667 | lhorky@partners.org |
| Contact: Masha Gaber, BS | 617 582-4755 | mgaber@partners.org |
Locations
| United States, California | |
| University of California at San Diego | Recruiting |
| San Diego, California, United States, 92093 | |
| Contact: Santosh Kesari, MD skesari@ucsd.edu | |
| Contact: Bradley Brown bdbrown@ucsd.edu | |
| Principal Investigator: Santosh Kesari, MD, PhD | |
| Sub-Investigator: Carl K Hoh, MD | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Laura L Horky, MD, PhD 617-732-8667 lhorky@partners.org | |
Sponsors and Collaborators
Brigham and Women's Hospital
Society of Nuclear Medicine and Molecular Imaging
General Electric
Investigators
| Principal Investigator: | Laura L Horky, MD, PhD | Brigham and Women's Hospital |
More Information
No publications provided
| Responsible Party: | Laura L. Horky, Instructor, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01240161 History of Changes |
| Other Study ID Numbers: | 2008P000554 |
| Study First Received: | November 10, 2010 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Brigham and Women's Hospital:
|
Glioblastoma multiforme FLT PET |
Additional relevant MeSH terms:
|
Brain Neoplasms Glioma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 22, 2013