Status:
COMPLETED
MRI and PET/FMISO In Assessing Tumor Hypoxia in Patients With Newly Diagnosed Glioblastoma Multiforme
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well positron emission tomography (PET) scan using 18F-fluoromisonidazole works when given together with magnetic resonance imaging (MRI) ) in assessing tumor hypox...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the association of baseline FMISO PET uptake (hypoxic volume \[HV\]), highest tumor:blood ratio \[T/Bmax\]) and MRI parameters (Ktrans, CBV) with overall survival ...
Eligibility Criteria
Inclusion
- Must be able to provide a written informed consent
- Newly diagnosed glioblastoma multiforme (GBM), World Health Organization (WHO) grade IV based on pathology confirmation
- Residual tumor after surgery (amount of residual tumor will not impact patient eligibility and visible residual disease can include T2/FLAIR hyperintensity)
- Note: If patient had a biopsy only, postoperative MRI is not needed to assess residual tumor prior to enrollment
- Scheduled to receive standard fractionated radiation therapy
- Scheduled to receive Temozolomide (TMZ) in addition to radiation therapy
- Karnofsky Performance Score \> 60
Exclusion
- Pregnant or breastfeeding (if a female is of child-bearing potential, and unsure of pregnancy status, a standard urine pregnancy test should be done)
- Scheduled to receive chemotherapy, immunotherapy, or investigational agents in trials unwilling to share data with ACRIN (i.e., additional therapy added to radiation and TMZ is allowed if ACRIN is able to obtain treatment information)
- Not suitable to undergo MRI or use the contrast agent Gd because of:
- Claustrophobia
- Presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
- Sickle cell disease
- Renal failure
- Reduced renal function, as determined by Glomerular Filtration Rate (GFR) \< 30 mL/min/1.73 m\^2 based on a serum creatinine level obtained within 28 days prior to registration
- Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject
- Presence of serious systemic illness, including: uncontrolled intercurrent infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations which might impact the survival endpoint of the study or limit compliance with study requirements
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to FMISO; an allergic reaction to nitroimidazoles is highly unlikely
- Not suitable to undergo PET or MRI, including weight greater than 350 lbs (the weight limit for the MRI and PET table)
- Prior treatment with implanted radiotherapy or chemotherapy sources such as wafers of polifeprosan 20 with carmustine
Key Trial Info
Start Date :
August 24 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00902577
Start Date
August 24 2009
End Date
January 31 2018
Last Update
April 8 2019
Active Locations (14)
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1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287