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Feasibility of FMISO in Brain Tumors

ConditionMalignant Brain Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute

About this trial

This phase II trial studies how well ¹⁸F- fluoromisonidazole (FMISO) works with positron emission tomography (PET)/magnetic resonance imaging (MRI) in assessing participants with malignant (cancerous) brain tumors. FMISO provides information about the oxygen levels in a tumor, which may affect how the tumor behaves. PET/MRI imaging produces images of the brain and how the body functions. FMISO PET/MRI may help investigators see how much oxygen is getting in the brain tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (greater than 18 years of age) with a known or suspected intracranial tumor.

Able to provide informed written consent and/or acceptable surrogate capable of providing consent on the patient's behalf.

Legally authorized representative (LAR)-signed informed consent and assent obtained for those subjects identified as decisionally impaired

Intracranial lesion known or suspected to be neoplastic greater than 10 mL as assessed by T2/fluid attenuated inversion recovery (FLAIR) MR imaging.

Disqualifiers

Pregnant or breast feeding.

Contraindication to PET, MRI, FMISO, or intravenous gadolinium based contrast agents.

Claustrophobia.

Weight greater than modality maximum capacity.

Trial design

Design model

Single group

Treatments tested in this trial

  • ¹⁸F-Fluoromisonidazole

    Drug

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo PET/MRI or PET/CT

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/MRI

  • Oxygen Therapy

    Procedure/Surgery

    Receive supplemental oxygen

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Diagnostic (FMISO, PET/MRI or PET/CT)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Macro-imaging level feasibility

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, and tissue oxygen maps). Images generated during the administration of oxygen will be used to generate tissue oxygen maps of the brain. 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 PET/MRI metrics in 85% of the initial cohort successfully imaged will need to be achieved for the imaging modality to be deemed feasible for this study. The estimated proportion of success rate for each metric along with the corresponding 95% binomial confidence interval will be provided.

Time frame
One day of diagnostic imaging
2

MRI contrast enhancement

Measured by Response assessment in neuro-oncology criteria sum product diameter assessment. The primary outcomes for this aim are enhancement mismatch ratio and hypoxic volume. Differences in imaging metrics will be evaluated using two sample t-test. If normal assumption is not satisfied, data transformation, or 95% confidence intervals based on bootstrapping method will be used. Exploratory analysis will assess diagnostic performance of imaging metrics (mismatch ratio and hypoxic volume) to identify pseudoprogression at earlier imaging dates.

Time frame
Up to 5 years

Secondary outcomes

1

Technical feasibility of PET/MRI

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.

Time frame
Baseline to the start of long-term follow-up (up to 5 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OHSU Knight Cancer Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Oregon Health and Science University

Collaborator

Weill Cornell University

Collaborator

Source ClinicalTrials.gov
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