search
Back to results

Oxygen-Enhanced MRI for Generating Hypoxia Maps in Patients With Intracranial Tumors

Primary Purpose

Intracranial Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance Imaging
Oxygen Therapy
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intracranial Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients (18 years of age or older) 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) magnetic resonance (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 breastfeeding Contraindication to supplemental oxygen administration, MRI, 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 Unsure of pregnancy status as assessed by Department of Radiology and Advanced Imaging Research Center (AIRC) guidelines Subjects for whom supplemental oxygen could be harmful such as people with potential for hypoventilation or chronic respiratory insufficiency (end-stage chronic obstructive pulmonary disease [COPD], obstructive sleep apnea [OSA] on continuous positive airway pressure [CPAP]/biphasic positive airway pressure [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

Sites / Locations

  • OHSU Knight Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (oxygen-enhanced MRI)

Arm Description

Patients receive supplemental oxygen while undergoing standard of care MRI.

Outcomes

Primary Outcome Measures

Generation of whole brain oxygen magnetic resonance imaging (MRI) data set
Evaluated to determine the feasibility of obtaining oxygen MRI hypoxia maps. Following completion of cohort enrollment, the generation of each hypoxia map will be independently scored as a dichotomous variable; successful or non-successful. The successful generation of a hypoxia map from either a T1 or T2* approach in 85% of the cohort of patients will need to be achieved for the imaging modality to be deemed feasible for the purposes of this study. Will provide the estimated proportion of success rate for each metric along with the corresponding 95% exact confidence interval.
Quantification of hypoxic tumor volume
Evaluated to determine the feasibility of obtaining oxygen MRI hypoxia maps.

Secondary Outcome Measures

Correlation between T1 and T2* sequence hypoxia volume
Will determine the association between oxygen MRI hypoxia maps generated using T2* and T1 MRI sequences. Assessed using Pearson's correlation coefficient.
Progression free survival
Will perform Kaplan Meier analysis of progression free survival stratified by median T1 and T2* hypoxic volume to determine the association between oxygen MRI hypoxia maps and progression free survival. A Cox regression model will also be explored by treating hypoxic volume as a continuous variable.

Full Information

First Posted
June 6, 2023
Last Updated
June 6, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University
search

1. Study Identification

Unique Protocol Identification Number
NCT05904704
Brief Title
Oxygen-Enhanced MRI for Generating Hypoxia Maps in Patients With Intracranial Tumors
Official Title
Feasibility of Oxygen Enhanced MRI in Assessment of Malignant Brain Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
April 12, 2024 (Anticipated)
Study Completion Date
April 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This clinical trial evaluates the feasibility of performing oxygen-enhanced magnetic resonance imaging (MRI) to generate hypoxia maps in patients with intracranial tumors. Decreased levels of oxygen (hypoxia) is a hallmark of malignant brain tumors. Chronic hypoxia is a stimulator of blood vessel formation, which is required for tumor growth and spread. Hypoxia also limits the effectiveness of radiation and chemotherapy. MRI is an imaging technique that uses radiofrequency waves and a strong magnetic field rather than x-rays to provide detailed pictures of internal organs and tissues. The administration of inhaled oxygen allows for an increased MRI signal effect size. Oxygen-enhanced MRI may be a non-invasive method that can physiologically estimate tissue hypoxia. With a better understanding of the extent of tumor hypoxia, more effective and patient-specific therapies could be devised to halt malignant tumor growth.
Detailed Description
PRIMARY OBJECTIVE: I. Determine the feasibility of generating hypoxia maps from oxygen MRI. SECONDARY OBJECTIVES: I. Evaluate the association between oxygen MRI hypoxia maps generated using T2* and T1 MRI sequences. II. Evaluate the association between oxygen MRI hypoxia maps and progression free survival. OUTLINE: Patients receive supplemental oxygen while undergoing standard of care MRI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Neoplasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (oxygen-enhanced MRI)
Arm Type
Experimental
Arm Description
Patients receive supplemental oxygen while undergoing standard of care MRI.
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MRI
Intervention Type
Procedure
Intervention Name(s)
Oxygen Therapy
Other Intervention Name(s)
supplemental oxygen therapy
Intervention Description
Receive supplemental oxygen
Primary Outcome Measure Information:
Title
Generation of whole brain oxygen magnetic resonance imaging (MRI) data set
Description
Evaluated to determine the feasibility of obtaining oxygen MRI hypoxia maps. Following completion of cohort enrollment, the generation of each hypoxia map will be independently scored as a dichotomous variable; successful or non-successful. The successful generation of a hypoxia map from either a T1 or T2* approach in 85% of the cohort of patients will need to be achieved for the imaging modality to be deemed feasible for the purposes of this study. Will provide the estimated proportion of success rate for each metric along with the corresponding 95% exact confidence interval.
Time Frame
One hour of diagnostic imaging
Title
Quantification of hypoxic tumor volume
Description
Evaluated to determine the feasibility of obtaining oxygen MRI hypoxia maps.
Time Frame
One hour of diagnostic imaging
Secondary Outcome Measure Information:
Title
Correlation between T1 and T2* sequence hypoxia volume
Description
Will determine the association between oxygen MRI hypoxia maps generated using T2* and T1 MRI sequences. Assessed using Pearson's correlation coefficient.
Time Frame
One hour of diagnostic imaging
Title
Progression free survival
Description
Will perform Kaplan Meier analysis of progression free survival stratified by median T1 and T2* hypoxic volume to determine the association between oxygen MRI hypoxia maps and progression free survival. A Cox regression model will also be explored by treating hypoxic volume as a continuous variable.
Time Frame
Clinical follow up for up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (18 years of age or older) 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) magnetic resonance (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 breastfeeding Contraindication to supplemental oxygen administration, MRI, 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 Unsure of pregnancy status as assessed by Department of Radiology and Advanced Imaging Research Center (AIRC) guidelines Subjects for whom supplemental oxygen could be harmful such as people with potential for hypoventilation or chronic respiratory insufficiency (end-stage chronic obstructive pulmonary disease [COPD], obstructive sleep apnea [OSA] on continuous positive airway pressure [CPAP]/biphasic positive airway pressure [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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramon Barajas
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramon Barajas
Phone
503-494-3408
Email
RADResearch@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Ramon Barajas

12. IPD Sharing Statement

Learn more about this trial

Oxygen-Enhanced MRI for Generating Hypoxia Maps in Patients With Intracranial Tumors

We'll reach out to this number within 24 hrs