Recruiting
Phase 2

FMISO

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT03649880

Conditions

Malignant Brain Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

¹⁸F-Fluoromisonidazole

Computed Tomography

Magnetic Resonance Imaging

Positron Emission Tomography

Oxygen Therapy

Study Details

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.

Conditions

Malignant Brain Neoplasm

Study ID

NCT03649880

Start date

Jun 1, 2019

Status verified date

Mar, 2025

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • 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.
  • Subjects for whom supplemental oxygen could be harmful such as people with potential for hypoventilation (end-stage COPD, OSA on CPAP/Bi-PAP, etc).
  • Subjects with a relative contraindication to supplemental oxygen administration will not be provided oxygen but may still participate in the study.
  • Presence of any other co-existing condition that, in the judgment of the principal investigator, might increase the risk to the subject (i.e., plans for hospice or end of life care).
  • 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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (FMISO, PET/MRI or PET/CT)

Participants receive FMISO intravenously (IV). Participants also undergo dynamic PET/computed tomography (CT) or PET/MRI over 120 minutes beginning 1 minute prior to FMISO injection, and static PET/CT or PET/MRI over 20-40 minutes approximately 90 minutes after FMISO injection. Participants then undergo a retest examination within 7 days. Participants may undergo 2 more PET/MRI or PET/CT scans no sooner than every 4 weeks. Supplemental oxygen may be administered to effect MRI signal.

Interventions

¹⁸F-Fluoromisonidazole

Given IV

Computed Tomography

Undergo PET/CT

Magnetic Resonance Imaging

Undergo PET/MRI or PET/CT

Positron Emission Tomography

Undergo PET/MRI

Oxygen Therapy

Receive supplemental oxygen

Primary outcome measure

  • Macro-imaging level feasibility [ Time Frame: One day of diagnostic imaging ]
  • MRI contrast enhancement [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Ramon Barajas

503-494-3408RADResearch@ohsu.edu

Principal Investigator:

Ramon Barajas

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

Mar 25, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2025-03-25.