Feasibility of FMISO in Brain Tumors
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|ClinicalTrials.gov Identifier: NCT03649880|
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : March 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Malignant Brain Neoplasm||Drug: ¹⁸F-Fluoromisonidazole Procedure: Computed Tomography Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography||Phase 2|
I. Determine the feasibility of obtaining FMISO PET (hypoxic volume and tumor to blood background values [T/B]) and dynamic susceptibility contrast enhanced (DSC) & diffusion-weighted imaging (DWI) MRI measures in patients with intracranial brain tumors.
I. Determine the feasibility of baseline and follow-up FMISO PET and MR imaging co-registration.
I. Determine the reproducibility of the baseline FMISO PET imaging metrics as assessed by baseline "test" and "retest" experiments.
Participants receive ¹⁸F-fluoromisonidazole intravenously (IV) and 1.5 - 2 hours later undergo PET/CT or PET/MRI over 20-40 minutes and a retest examination within 7 days. Participants may undergo 2 more PET/MRI scans no sooner than every 4 weeks.
After conclusion of the diagnostic tests, participants are followed for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of [¹⁸F]-Fluoromisonidazole (FMISO) in Assessment of Malignant Brain Tumors|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2024|
Experimental: Diagnostic (FMISO, PET/MRI or PET/CT)
Participants receive ¹⁸F-fluoromisonidazole IV and 1.5 - 2 hours later undergo PET (Positron Emission Tomography)/CT (Computed Tomography) or PET/MRI (Magnetic Resonance Imaging) over 20-40 minutes and a retest examination within 7 days. Participants may undergo 2 more PET/MRI scans no sooner than every 4 weeks
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
- Macro-imaging level feasibility [ Time Frame: One day of diagnostic imaging ]Will be assessed as a factor of generating quantitative positron emission tomography (PET)/magnetic resonance imaging (MRI) metrics (intra-tumoral FMISO tumor to blood [T/B] level, hypoxic volume, dynamic susceptibility contrast enhanced [DSC], and diffusion-weighted imaging [DWI] values). Following completion of cohort enrollment, the generation of each quantitative PET/MRI metric will be independently scored as a dichotomous variable; successful or non-successful. Proportional assessment will be performed to assess for project feasibility. The successful generation of quantitative PET/MRI metrics in 85% of the initial cohort of patients successfully imaged for research purposes will need to be achieved for the imaging modality to be deemed feasible for the purposes of this study. The estimated proportion of success rate for each metric along with the corresponding 95% binomial confidence interval will be provided.
- Technical feasibility of PET/MRI [ Time Frame: Baseline to the start of long-term follow-up (up to 5 years) ]The generation of co-registered imaging data sets will be independently scored as a dichotomous variable; successful or non-successful (< 10mm versus [vs.] > 10mm alignment error). Proportional assessment will be performed to assess for project feasibility. The estimated proportion along with the corresponding 95% binomial confidence interval will be provided.
- Change in tumor (FLAIR) region from baseline [ Time Frame: Baseline to the start of long-term follow-up (up to 5 years) ]A Wilcoxon signed rank test will be used to test the hypothesis that ¹⁸F-Fluoromisonidazole (FMISO) values observed within the T2/fluid attenuated inversion recovery (FLAIR) hyperintense region of the tumor following therapy will undergo a statistically significant change when compared to baseline pre-therapeutic values.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649880
|United States, Oregon|
|OHSU Knight Cancer Institute||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Ramon Barajas 503-494-3408 RADResearch@ohsu.edu|
|Principal Investigator: Ramon Barajas|
|Principal Investigator:||Ramon Barajas||OHSU Knight Cancer Institute|