Clinical trial NCT03649880: Feasibility of FMISO in Brain Tumors
Official title: Feasibility of [¹⁸F]-Fluoromisonidazole (FMISO) in Assessment of Malignant Brain Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Malignant Brain Neoplasm
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Oregon Health and Science University
name: Weill Cornell University
First posted: 2018-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: PRIMARY OBJECTIVES:

I. Determine the feasibility of obtaining ¹⁸F- fluoromisonidazole (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.

II. Determine if MRI contrast-enhancement and hypoxic volume are imaging profiles of glioblastoma immunotherapy-mediated pseudoprogression or true progression in a clinical trial.

SECONDARY OBJECTIVE:

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

TERTIARY OBJECTIVE:

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

OUTLINE:

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.

After conclusion of the diagnostic tests, participants are followed for up to 5 years.

Eligibility criteria: 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.

Primary outcomes:
measure: Macro-imaging level feasibility
timeFrame: One day of diagnostic imaging
measure: MRI contrast enhancement
timeFrame: Up to 5 years
Secondary outcomes:
measure: Technical feasibility of PET/MRI
timeFrame: Baseline to the start of long-term follow-up (up to 5 years)
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Ramon Barajas
role: PRINCIPAL_INVESTIGATOR
References: