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

Intracranial Neoplasm Clinical Trial

Official title:

Feasibility of Oxygen Enhanced MRI in Assessment of Malignant Brain Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05904704
• Other study ID #: STUDY00025277
• Secondary ID: NCI-2023-01433ST
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: March 31, 2029

Study information

• Verified date: March 2024
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2029
• Est. primary completion date: March 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Intracranial Neoplasm

Intervention

Procedure:
• Magnetic Resonance Imaging
Undergo MRI
• Oxygen Therapy
Receive supplemental oxygen

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One hour of diagnostic imaging
Primary	Quantification of hypoxic tumor volume	Evaluated to determine the feasibility of obtaining oxygen MRI hypoxia maps.	One hour of diagnostic imaging
Secondary	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.	One hour of diagnostic imaging
Secondary	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.	Clinical follow up for up to 5 years