Overview

This trial is active, not recruiting.

Conditions adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma
Treatments 18f-fluoromisonidazole, magnetic resonance imaging, positron emission tomography
Phase phase 2
Sponsor National Cancer Institute (NCI)
Start date August 2009
End date January 2018
Trial size 50 participants
Trial identifier NCT00902577, ACRIN 6684, ACRIN-6684, CDR0000640413, NCI-2011-01912, U01CA080098

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 hypoxia in patients with newly diagnosed glioblastoma multiforme (GBM). Diagnostic procedures, such as MRI and PET scan using 18F-fluoromisonidazole (FMISO), may help predict the response of the tumor to the treatment and allow doctors to plan better treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Two weeks before initiation of chemoradiotherapy with temozolomide, patients undergo MRI and PET scan using FMISO. A subset of 15 patients undergo FMISO PET scans approximately 1 week before chemoradiotherapy.
18f-fluoromisonidazole 18F-MISO
Undergo FMISO PET scans
magnetic resonance imaging Magnetic Resonance Imaging Scan
Undergo MRI
positron emission tomography Medical Imaging, Positron Emission Tomography
Undergo FMISO PET scan

Primary Outcomes

Measure
Association of baseline FMISO PET uptake (HV and T/Bmax) and MRI parameters (Ktrans and CBV) with OS as assessed using Cox-regression model
time frame: Up to 5 years after completion of study

Secondary Outcomes

Measure
Association of baseline FMISO PET uptake (HV and T/Bmax) and MRI parameters (Ktrans and CBV) with TTP and PFS-6 as assessed using multi-variate Cox model and multi-variate Logistic regression model
time frame: Up to 5 years after completion of study
Correlation between other MRI parameters (T1Gd, VCI, small vessel CBV, ADC, NAA-Cho ratio, changes in BOLD signal, and T2 lesion volume) and OS, TTP, and PFS-6
time frame: Up to 5 years after completion of study
Correlation between T/Cmax and T/Bmax
time frame: At baseline, week 4, and week 10
Reproducibility of the baseline FMISO PET uptake parameters as assessed by baseline "test" and "retest" PET scans
time frame: Baseline and retest within 1 to 7 days after (but prior to the start of therapy)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Must be able to provide a written informed consent - Newly diagnosed 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 TMZ in addition to radiation therapy - Karnofsky Performance Score > 60 Exclusion Criteria: - 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 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

Additional Information

Official title Multicenter, Phase II Assessment of Tumor Hypoxia in Glioblastoma Using 18F-Fluoromisonidazole (FMISO) With PET and MRI
Principal investigator Elizabeth Gerstner
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 (OS) in participants with newly diagnosed GBM. SECONDARY OBJECTIVES: I. To determine the association of baseline FMISO PET uptake (HV, T/Bmax) and MRI parameters (Ktrans, CBV) with time to progression (TTP) and 6-month progression free survival (PFS-6) in participants with newly diagnosed GBM. II. To assess the reproducibility of the baseline FMISO PET uptake parameters by implementing baseline "test" and "retest" PET scans (performed within 1 to 7 days of each other). III. To assess the correlation between highest tissue:cerebellum ratio [T/Cmax] and T/Bmax at baseline. IV. To assess the correlation between other MRI parameters (T1Gd, VCI, CBV-S, ADC, NAA-Cho, BOLD, T2) and OS, TTP, and PFS-6. OUTLINE: This is a multicenter study. Two weeks before initiation of chemoradiotherapy with temozolomide, patients undergo MRI and PET scan using FMISO. A subset of 15 patients undergo FMISO PET scans approximately 1 week before chemoradiotherapy. Blood samples are collected at baseline and periodically during study to compare image measures of tissue uptake of FMISO to blood concentrations. Tumor samples are collected from diagnostic biopsy or surgery for analysis of tumor hypoxic markers and methylguanine methyl transferase by immunohistochemical and PCR assays. After completion of study therapy, patients are followed up every 3 months for up to 5 years.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).