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Feasibility of FMISO in Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649880
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : March 12, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ramon Barajas, OHSU Knight Cancer Institute

Brief Summary:
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.

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

Detailed Description:

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

I. Determine the feasibility of baseline and follow-up FMISO PET and MR imaging co-registration.

TERTIARY OBJECTIVES:

I. Determine the reproducibility of the baseline FMISO PET imaging metrics as assessed by baseline "test" and "retest" experiments.

OUTLINE:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: ¹⁸F-Fluoromisonidazole
Given IV
Other Names:
  • ¹⁸F-MISO
  • ¹⁸F-Misonidazole
  • FMISO

Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT SCAN
  • tomography

Procedure: Magnetic Resonance Imaging
Undergo PET/MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Procedure: Positron Emission Tomography
Undergo PET/MRI
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients 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.
  • Intracranial lesion known or suspected to be neoplastic greater than 10 mL as assessed by T2/fluid attenuated inversion recovery (FLAIR) MR imaging.
  • Karnofsky performance score > 60 or Eastern Cooperative Oncology Group (ECOG) < 3 as assessed by referring clinician.
  • Planning to undergo or previously received therapeutic intervention for the intracranial tumor.

Exclusion Criteria:

  • Pregnant or breast feeding.
  • Contraindication to PET, MRI, FMISO, or intravenous gadolinium based contrast agents.

    • Claustrophobia.
    • Weight greater than modality maximum capacity.
    • Presence of metallic foreign body or implanted medical devices in body not documented as MRI safe according to the Oregon Health & Science University (OHSU) Department of Radiology guidelines (including but not limited to 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.
    • Reduced renal function, as determined by glomerular filtration rate (GFR) < 45 mL/min/1.73 m^2 based on a serum creatinine level obtained per OHSU Department of Radiology and Advanced Imaging Research Center (AIRC) clinical criteria.
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to FMISO. An allergic reaction to nitroimidazoles is highly unlikely.
    • Unsure of pregnancy status as assessed by Department of Radiology and AIRC guidelines.
  • Presence of any other co-existing condition that, in the judgment of the principal investigator, might increase the risk to the subject.
  • Poor peripheral intravenous access evaluated by patient history.
  • Presence of other serious systemic illnesses, including: uncontrolled infection, other uncontrolled malignancy, uncontrolled diabetes type II, or psychiatric/social situations which might impact the endpoint of the study or limit compliance with study requirements.

Information from the National Library of Medicine

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


Locations
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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         
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ramon Barajas OHSU Knight Cancer Institute

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Responsible Party: Ramon Barajas, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT03649880    
Other Study ID Numbers: STUDY00016043
NCI-2018-01479 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
STUDY00016043 ( Other Identifier: OHSU Knight Cancer Institute )
P01CA042045 ( U.S. NIH Grant/Contract )
P30CA069533 ( U.S. NIH Grant/Contract )
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Misonidazole
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents