Malignant Brain NeoplasmNCT04460495
Quantifying Oxygen Utilization of Tumors Using Oxygen-Enhanced Molecular MRI
A study testing Arterial Spin Labeling Magnetic Resonance Imaging, pH-Weighted amine CEST and Oxygen-weighted SAGE-EPI in people with Malignant Brain Neoplasm, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This trial looks to study the safety and feasibility of using oxygen-enhanced molecular MRI to understand how cancer cells use oxygen differently than normal cells. Cancer cells tend to utilize (or not utilize) oxygen differently than normal cells. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malignant Brain Neoplasm
- What is being tested?
- Arterial Spin Labeling Magnetic Resonance Imaging, pH-Weighted amine CEST and Oxygen-weighted SAGE-EPI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to 16 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy volunteers will include persons who at the time of scans do not present with known neurological conditions that might impact tissue imaging results
- Patient participants should have suspected or pathology-confirmed diagnosis of a brain tumor (any histological subtype including brain metastases)
- All participants must be able to obtain an MRI scan and must be able to safely breathe high concentrations of oxygen
Who cannot join
- Participants with contraindications to MRI including metal implants
- Participants who are deemed not able to or not safe to breath high concentrations of oxygen
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Quantifying Tumor Respiration Using Oxygen-Enhanced Molecular MRI
This trial looks to study the safety and feasibility of using oxygen-enhanced molecular MRI to understand how cancer cells use oxygen differently than normal cells. Cancer cells tend to utilize (or not utilize) oxygen differently than normal cells. By using the oxygen-enhanced molecular MRI, researchers will be able to create spatial "maps" depicting areas of abnormal oxygen utilization unique to cancer. This type of information may be useful for diagnosing new cancers, understanding various "subtypes" of cancer that might utilize oxygen differently, or this information may be useful for evaluating new drugs that impact cancer metabolism.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the safety, feasibility, and sensitivity of oxygen-enhanced molecular magnetic resonance imaging (MRI) in healthy volunteers.
II. Measure oxygen-enhanced molecular MRI characteristics in human brain tumors.
OUTLINE:
Participants undergo arterial spin labeling (ASL) MRI scan and amine chemical exchange saturation transfer spin-and-gradient echo echo-planar imaging using amine proton CEST echo spin-and-gradient echo (SAGE) EPI (CEST-SAGE-EPI) while breathing normal room air (21% oxygen). Patients then undergo another ASL MRI and CEST-SAGE-EPI while breathing medical grade air (100% oxygen). Total ASL MRI and CEST-SAGE-EPI imaging scan time is 60 minutes.
- Conditions
- Malignant Brain Neoplasm
- Being tested
- Arterial Spin Labeling Magnetic Resonance Imaging, pH-Weighted amine CEST, Oxygen-weighted SAGE-EPI
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial Spin Labeling Magnetic Resonance ImagingProcedure or surgery
Also called ARTERIAL SPIN LABELING FUNCTIONAL MRI, Arterial Spin Labeling MRI, ASL, ASL fMRI
Undergo ASL scan
pH-Weighted amine CESTProcedure or surgery
Also called Amine CEST, CEST-EPI
Undergo pH Weighted amine CEST
Oxygen-weighted SAGE-EPIProcedure or surgery
Also called SAGE-EPI, Hypoxia MRI
Undergo Oxygen-weighted SAGE-EPI
| Study group | Role | What they receive |
|---|---|---|
| Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI) | Experimental | Participants undergo ASL perfusion, pH-weighted amine CEST, and oxygen-weighted SAGE-EPI , while breathing normal room air (21% oxygen). Patients then undergo another ASL perfusion, pH-weighted amine CEST, and oxygen-weighted SAGE-EPI while breathing medical grade air (100% oxygen). Total ASL perfusion, pH-weighted amine CEST, and oxygen-weighted SAGE-EPI imaging scan time is 60 minutes. Receives: Procedure: Arterial Spin Labeling Magnetic Resonance Imaging; Procedure: pH-Weighted amine CEST; Procedure: Oxygen-weighted SAGE-EPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pH-weighted amine CEST MRI to measure tumor acidity (MTRasym at 3ppm) before/after oxygen enrichment
Will be measured by voxel-wise t-tests via analysis of functional NeuroImages (AFNI) software between the average R2' and MTRasym during normal room air and medical grade air.
Measured: Baseline and two hours after Oxygen enrichment
Change in oxygen-weighted SAGE-EPI to measure oxygen extraction (R2') before and after oxygen enrichment
We will perform voxel-wise t-tests via AFNI software between the average R2' and MTRasym during normal room air and medical grade air.
Measured: Baseline and two hours after Oxygen enrichment
Tumor blood flow as measured by cerebral blood flow (CBF) from arterial spin labeling (ASL).
Change in ASL perfusion estimates of relative cerebral blood flow (CBF) before and after oxygen enrichment
Measured: Baseline and two hours after Oxygen enrichment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start7 Jul 2020
- Primary completion16 Sep 2021
- Study completion16 Sep 2021
Why it stopped: insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Brain NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- oxygen-enhanced molecular MRI in healthy volunteers.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin M Ellingson, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460495
- Sponsor's protocol ID
- 20-000449
- Other IDs
- NCI-2020-03446
- Status last verified
- May 2022
- First submitted
- 15 Jun 2020
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Tumor Respiration Using Oxygen-Enhanced Molecular MRI
- ClinicalTrials.gov ID
- NCT04460495
- Acronym / sponsor ID
- 20-000449
- Conditions
- Malignant Brain Neoplasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial looks to study the safety and feasibility of using oxygen-enhanced molecular MRI to understand how cancer cells use oxygen differently than normal cells. Cancer cells tend to utilize (or not utilize) oxygen differently than normal cells. By using the oxygen-enhanced molecular MRI, researchers will be able to create spatial "maps" depicting areas of abnormal oxygen utilization unique to cancer. This type of information may be useful for diagnosing new cancers, understanding various "subtypes" of cancer that might utilize oxygen differently, or this information may be useful for evaluating new drugs that impact cancer metabolism.
Detailed description
PRIMARY OBJECTIVES:
- Determine the safety, feasibility, and sensitivity of oxygen-enhanced molecular magnetic resonance imaging (MRI) in healthy volunteers.
II. Measure oxygen-enhanced molecular MRI characteristics in human brain tumors.
OUTLINE:
Participants undergo arterial spin labeling (ASL) MRI scan and amine chemical exchange saturation transfer spin-and-gradient echo echo-planar imaging using amine proton CEST echo spin-and-gradient echo (SAGE) EPI (CEST-SAGE-EPI) while breathing normal room air (21% oxygen). Patients then undergo another ASL MRI and CEST-SAGE-EPI while breathing medical grade air (100% oxygen). Total ASL MRI and CEST-SAGE-EPI imaging scan time is 60 minutes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- oxygen-enhanced molecular MRI in healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI) | Experimental | Procedure: Arterial Spin Labeling Magnetic Resonance Imaging, Procedure: pH-Weighted amine CEST, Procedure: Oxygen-weighted SAGE-EPIParticipants undergo ASL perfusion, pH-weighted amine CEST, and oxygen-weighted SAGE-EPI , while breathing normal room air (21% oxygen). Patients then undergo another ASL perfusion, pH-weighted amine CEST, and oxygen-weighted SAGE-EPI while breathing medical grade air (100% oxygen). Total ASL perfusion, pH-weighted amine CEST, and oxygen-weighted SAGE-EPI imaging scan time is 60 minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers will include persons who at the time of scans do not present with known neurological conditions that might impact tissue imaging results
- Patient participants should have suspected or pathology-confirmed diagnosis of a brain tumor (any histological subtype including brain metastases)
- All participants must be able to obtain an MRI scan and must be able to safely breathe high concentrations of oxygen
Key exclusion criteria (2 listed)
- Participants with contraindications to MRI including metal implants
- Participants who are deemed not able to or not safe to breath high concentrations of oxygen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial Spin Labeling Magnetic Resonance ImagingAlso: ARTERIAL SPIN LABELING FUNCTIONAL MRI, Arterial Spin Labeling MRI, ASL, ASL fMRIUndergo ASL scan | Procedure or surgery | Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI) |
| pH-Weighted amine CESTAlso: Amine CEST, CEST-EPIUndergo pH Weighted amine CEST | Procedure or surgery | Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI) |
| Oxygen-weighted SAGE-EPIAlso: SAGE-EPI, Hypoxia MRIUndergo Oxygen-weighted SAGE-EPI | Procedure or surgery | Feasibility (ASL,pH-Weighted amine CEST, O2-Weighted SAGE-EPI) |
Primary outcome
Change in pH-weighted amine CEST MRI to measure tumor acidity (MTRasym at 3ppm) before/after oxygen enrichment
Time frame: Baseline and two hours after Oxygen enrichment
Will be measured by voxel-wise t-tests via analysis of functional NeuroImages (AFNI) software between the average R2' and MTRasym during normal room air and medical grade air.
Change in oxygen-weighted SAGE-EPI to measure oxygen extraction (R2') before and after oxygen enrichment
Time frame: Baseline and two hours after Oxygen enrichment
We will perform voxel-wise t-tests via AFNI software between the average R2' and MTRasym during normal room air and medical grade air.
Tumor blood flow as measured by cerebral blood flow (CBF) from arterial spin labeling (ASL).
Time frame: Baseline and two hours after Oxygen enrichment
Change in ASL perfusion estimates of relative cerebral blood flow (CBF) before and after oxygen enrichment
Results and safety
The study was stopped early (reason given: insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin M Ellingson principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial Spin Labeling Magnetic Resonance Imaging, pH-Weighted amine CEST and Oxygen-weighted SAGE-EPI in people with Malignant Brain Neoplasm, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pH-weighted amine CEST MRI to measure tumor acidity (MTRasym at 3ppm) before/after oxygen enrichment (time frame: Baseline and two hours after Oxygen enrichment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.