RECRUITING

Feasibility of FMISO in Brain Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Feasibility of [¹⁸F]-Fluoromisonidazole (FMISO) in Assessment of Malignant Brain Tumors

Quick Facts

Study Start:2019-06-01

Study Completion:2030-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03649880

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Ramon Barajas

PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Study Locations (Sites)

OHSU Knight Cancer Institute

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: OHSU Knight Cancer Institute

Ramon Barajas, PRINCIPAL_INVESTIGATOR, OHSU Knight Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-01

Study Completion Date2030-01-31

Study Record Updates

Study Start Date2019-06-01

Study Completion Date2030-01-31

Terms related to this study

Additional Relevant MeSH Terms

Malignant Brain Neoplasm