To hear about similar clinical trials, please enter your email below
Trial Title:
Oxygen-Enhanced MRI for Generating Hypoxia Maps in Patients With Intracranial Tumors
NCT ID:
NCT05904704
Condition:
Intracranial Neoplasm
Conditions: Official terms:
Brain Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Diagnostic (oxygen-enhanced MRI)
Other name:
Magnetic Resonance
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Procedure
Intervention name:
Oxygen Therapy
Description:
Receive supplemental oxygen
Arm group label:
Diagnostic (oxygen-enhanced MRI)
Other name:
supplemental oxygen therapy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
OHSU Knight Cancer Institute
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ramon Barajas
Phone:
503-494-3408
Email:
RADResearch@ohsu.edu
Investigator:
Last name:
Ramon Barajas
Email:
Principal Investigator
Start date:
April 12, 2023
Completion date:
March 31, 2029
Lead sponsor:
Agency:
OHSU Knight Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Oregon Health and Science University
Agency class:
Other
Source:
OHSU Knight Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05904704
