Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
Study NCT ID:
NCT05904704
Status:
WITHDRAWN
Last Update Posted:
2025-11-14
First Post:
2023-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oxygen-Enhanced MRI for Generating Hypoxia Maps in Patients With Intracranial Tumors
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
Feasibility of Oxygen Enhanced MRI in Assessment of Malignant Brain Tumors
Status:
WITHDRAWN
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: