Brain TumorNCT06101069
Development of MRF for Characterization of Brain Tumors After Radiotherapy
A study testing MRF in conjunction with IVIM MRI without contrast in people with Brain Tumor and Brain Necrosis, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging (MRI) technique, named Magnetic Resonance Fingerprinting (or MRF), to achieve high-quality images within a short scan time of 5 min for viewing the entire brain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Tumor, Brain Necrosis, Brain Metastases
- What is being tested?
- MRF in conjunction with IVIM MRI without contrast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18 - 60
- No history of cerebrovascular disease
- No cognitive impairments
- Able to provide informed consent
- Biopsy-proven cases of developed recurrent tumor or radiation necrosis, OR
- a. PET identified with developed recurrent tumor or radiation necrosis. OR
Show all 26Show fewer
- b. Highly suspicious case with developed recurrent tumor or radiation necrosis confirmed by tumor board, attending physician or surgeon.
- Age: 18 years and over
- ECOG performance status 0-2.
- Life expectancy > 6 months.
- Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.
- Inclusion Criteria for Participants with Brain Metastases or Primary Gliomas:
- Radiology identified with developed primary gliomas tumor or brain metastases, OR
- a. PET identified with developed gliomas tumor or brain metastases, OR
- b. Highly suspicious case with developed gliomas tumor or brain metastases confirmed by tumor board
- Participants must not have received prior radiation or surgical treatment for brain metastases or primary glioma.
- Age: 18 years and over
- ECOG performance status 0-2
- Life expectancy > 6 months.
- Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.
- Radiology identified with resectable meningioma
- Participants have no prior radiation or surgical treatment for brain lesions
- Age: 18 years or older
- ECOG performance status 0-2
- Life expectancy > 6 months.
- Participants with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.
Who cannot join
- Pregnant women OR lactating women
- Participants with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
- Participants who cannot go into the MRI scanner due to metal implants and other medical conditions.
- The presence of an implanted medical device that is not MRI-compatible, including, but not limited to: pacemaker, defibrillator.
- Participants with contraindications for MRI due to embedded foreign metallic objects such as bullets, shrapnel, metalwork fragments, or other metallic material.
- Known history of severe claustrophobia.
- Participants under the age of 18
- Participants unable to lay still in the scanner for 30 minutes at a time.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Chaitra A Badve, MD
- Recruiting
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Lan Lu, PhD, 866-223-8100
Lan Lu, PhD
About this study
Official title: Development of Magnetic Resonance Fingerprinting for Characterization of Brain Tumors After Radiotherapy
The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging (MRI) technique, named Magnetic Resonance Fingerprinting (or MRF), to achieve high-quality images within a short scan time of 5 min for viewing the entire brain. This is an advanced quantitative assessment of brain tissues. This method is being applied with IVIM MRI to be able to tell the difference between a brain with radiation necrosis and a brain with tumor recurrence. Participants will consist of individuals who have received radiation therapy in the past and were diagnosed with radiation necrosis, individuals with recurrent tumors, individuals with previously untreated tumors, and healthy individuals who have no brain diseases and have not had radiation treatment to the brain. Participants will undergo an MRI scan at a one-time research study visit; no extra tests or procedures will be required for this research study.
The primary objectives of this study are:
- To demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage.
- To apply the developed quantitative approach in combination with IVIM MRI for differentiation of tumor recurrence and radiation necrosis.
- To investigate the effect of radiation dose on the development of radiation necrosis and tumor recurrence.
Read the detailed description
Although Stereotactic radiosurgery (SRS) is utilized as an effective treatment method, after several months to over 1 year following SRS, 33% of treated brain metastases increase in size on imaging, which is suspicious for tumor progression. However, based on findings in follow-up biopsies, the majority of newly detected metastases on imaging are radiation treatment effects instead of active tumor. So far, the only gold standard to differentiate active tumor and radiation necrosis is surgical resection for pathologic confirmation, which is invasive, not favored for poor surgical candidates, and should be avoided in cases of necrosis. The existing clinical imaging techniques have poor sensitivity or specificity in differentiating these two types of tissues. Recently, a novel MRI data acquisition approach, namely MR Fingerprinting (MRF), has been introduced for the simultaneous measurement of multiple important parameters in a single MRI scan. In addition, quantitative diffusion MRI, such as the intravoxel incoherent motion (IVIM) technique, can provide a noninvasive and powerful tool to quantify microstructural information by measuring water diffusion and microcirculation perfusion in vivo. This study aims to demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage. It also aims to apply the developed quantitative approach in combination with IVIM MRI for the differentiation of tumor recurrence and radiation necrosis. The multi-parametric quantitative measures developed in this study could establish a new fundamental biomarker for the diagnosis and monitoring of brain tumors.
- Conditions
- Brain Tumor, Brain Necrosis, Brain Metastases, Glioma
- Being tested
- MRF in conjunction with IVIM MRI without contrast
- Keywords
- Magnetic Resonance Fingerprinting, Radiation necrosis
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRF in conjunction with IVIM MRI without contrastProcedure or surgery
MRF in conjunction with IVIM MRI scan, without contrast.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer Participants | Experimental | Healthy volunteers will be recruited to evaluate the capability of MRF in conjunction with intravoxel incoherent motion (IVIM) MRI and serve as healthy control data to compare with the participant data. Receives: Procedure: MRF in conjunction with IVIM MRI without contrast |
| Participants with Radiation Necrosis | Experimental | The MRI scans (MRF and IVIM) will be performed on participants with newly developed necrosis prior to any further therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings Receives: Procedure: MRF in conjunction with IVIM MRI without contrast |
| Participants with Tumor Recurrence | Experimental | The MRI scans (MRF and IVIM) will be performed on participants with newly developed recurrent prior to any further therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings Receives: Procedure: MRF in conjunction with IVIM MRI without contrast |
| Participants with Brain Metastases | Experimental | The MRI scans (MRF and IVIM) will be performed on participants with newly developed, untreated brain metastases prior to any therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings Receives: Procedure: MRF in conjunction with IVIM MRI without contrast |
| Participants with Primary Gliomas | Experimental | The MRI scans (MRF and IVIM) will be performed on participants with newly developed, untreated primary gliomas prior to any therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings Receives: Procedure: MRF in conjunction with IVIM MRI without contrast |
| Participants with Meningiomas | Experimental | The MRI scans (MRF and IVIM) will be performed on participants with meningiomas who have not yet undergone radiation or surgical treatment. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings Receives: Procedure: MRF in conjunction with IVIM MRI without contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of T1 relaxation times
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by the 3D-MRF T1 relaxation times. The difference in mean T1 between each cohort of participants will be measured.
Measured: Within the total 30-45 minute scan time
Comparison of T2 relaxation times
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by the 3D-MRF T2 relaxation times. The difference in mean T2 between each cohort of participants will be measured.
Measured: Within the total 30-45 minute scan time
Comparison of proton density maps
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the MRF proton density maps of each cohort of participants. This will be compared using a t-test.
Measured: Within the total 30-45 minute scan time
Comparison of water diffusion in brain tissues
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the diffusion parameters measured by the IVIM method between the three cohorts of participants. This will be compared using a t-test.
Measured: Within the total 30-45 minute scan time
Comparison of blood perfusion in brain tissues
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the perfusion parameters measured by the IVIM method between the three cohorts of participants. This will be compared using a t-test.
Measured: Within the total 30-45 minute scan time
Comparison of MRF imaging tool in different participant populations
The objective is to compare the effects of radiation dose on development of radiation and necrosis and tumor recurrence by comparing participants in all cohorts (healthy participants with no brain disease, participants with brain tumors (treated), participants with brain metastases or primary gliomas (previously untreated)). The predictive ability will be assessed by comparing univariable ROC analysis, quantified using area under the curve (AUC).
Measured: Within the total 30-45 minute scan time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start14 Oct 2024
- Primary completionJan 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, observational, multi-cohort, unblinded, single-center study.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Lan Lu, PhD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer CenterSamuel Chao, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101069
- Sponsor's protocol ID
- CASE3323
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Magnetic Resonance Fingerprinting for Characterization of Brain Tumors After Radiotherapy
- ClinicalTrials.gov ID
- NCT06101069
- Acronym / sponsor ID
- CASE3323
- Conditions
- Brain Tumor, Brain Necrosis, Brain Metastases, Glioma
- Keywords
- Magnetic Resonance Fingerprinting, Radiation necrosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 25 Oct 2023 (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.
The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging (MRI) technique, named Magnetic Resonance Fingerprinting (or MRF), to achieve high-quality images within a short scan time of 5 min for viewing the entire brain. This is an advanced quantitative assessment of brain tissues. This method is being applied with IVIM MRI to be able to tell the difference between a brain with radiation necrosis and a brain with tumor recurrence. Participants will consist of individuals who have received radiation therapy in the past and were diagnosed with radiation necrosis, individuals with recurrent tumors, individuals with previously untreated tumors, and healthy individuals who have no brain diseases and have not had radiation treatment to the brain. Participants will undergo an MRI scan at a one-time research study visit; no extra tests or procedures will be required for this research study.
The primary objectives of this study are:
- To demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage.
- To apply the developed quantitative approach in combination with IVIM MRI for differentiation of tumor recurrence and radiation necrosis.
- To investigate the effect of radiation dose on the development of radiation necrosis and tumor recurrence.
Detailed description
Although Stereotactic radiosurgery (SRS) is utilized as an effective treatment method, after several months to over 1 year following SRS, 33% of treated brain metastases increase in size on imaging, which is suspicious for tumor progression. However, based on findings in follow-up biopsies, the majority of newly detected metastases on imaging are radiation treatment effects instead of active tumor. So far, the only gold standard to differentiate active tumor and radiation necrosis is surgical resection for pathologic confirmation, which is invasive, not favored for poor surgical candidates, and should be avoided in cases of necrosis. The existing clinical imaging techniques have poor sensitivity or specificity in differentiating these two types of tissues. Recently, a novel MRI data acquisition approach, namely MR Fingerprinting (MRF), has been introduced for the simultaneous measurement of multiple important parameters in a single MRI scan. In addition, quantitative diffusion MRI, such as the intravoxel incoherent motion (IVIM) technique, can provide a noninvasive and powerful tool to quantify microstructural information by measuring water diffusion and microcirculation perfusion in vivo. This study aims to demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage. It also aims to apply the developed quantitative approach in combination with IVIM MRI for the differentiation of tumor recurrence and radiation necrosis. The multi-parametric quantitative measures developed in this study could establish a new fundamental biomarker for the diagnosis and monitoring of brain tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This is a prospective, observational, multi-cohort, unblinded, single-center study.
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer Participants | Experimental | Procedure: MRF in conjunction with IVIM MRI without contrastHealthy volunteers will be recruited to evaluate the capability of MRF in conjunction with intravoxel incoherent motion (IVIM) MRI and serve as healthy control data to compare with the participant data. |
| Participants with Radiation Necrosis | Experimental | Procedure: MRF in conjunction with IVIM MRI without contrastThe MRI scans (MRF and IVIM) will be performed on participants with newly developed necrosis prior to any further therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings |
| Participants with Tumor Recurrence | Experimental | Procedure: MRF in conjunction with IVIM MRI without contrastThe MRI scans (MRF and IVIM) will be performed on participants with newly developed recurrent prior to any further therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings |
| Participants with Brain Metastases | Experimental | Procedure: MRF in conjunction with IVIM MRI without contrastThe MRI scans (MRF and IVIM) will be performed on participants with newly developed, untreated brain metastases prior to any therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings |
| Participants with Primary Gliomas | Experimental | Procedure: MRF in conjunction with IVIM MRI without contrastThe MRI scans (MRF and IVIM) will be performed on participants with newly developed, untreated primary gliomas prior to any therapy implementation, surgical biopsy, or resection. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings |
| Participants with Meningiomas | Experimental | Procedure: MRF in conjunction with IVIM MRI without contrastThe MRI scans (MRF and IVIM) will be performed on participants with meningiomas who have not yet undergone radiation or surgical treatment. For the participants undergoing surgical biopsy or resection after the MRI scans, the findings from the analysis of pathological biopsied specimen will serve as pathological confirmation for the MRI imaging findings |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- Ages 18 - 60
- No history of cerebrovascular disease
- No cognitive impairments
- Able to provide informed consent
- Biopsy-proven cases of developed recurrent tumor or radiation necrosis, OR
Key exclusion criteria (8 listed)
- Pregnant women OR lactating women
- Participants with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
- Participants who cannot go into the MRI scanner due to metal implants and other medical conditions.
- The presence of an implanted medical device that is not MRI-compatible, including, but not limited to: pacemaker, defibrillator.
- Participants with contraindications for MRI due to embedded foreign metallic objects such as bullets, shrapnel, metalwork fragments, or other metallic material.
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 |
|---|---|---|
| MRF in conjunction with IVIM MRI without contrastMRF in conjunction with IVIM MRI scan, without contrast. | Procedure or surgery | Healthy Volunteer Participants, Participants with Brain Metastases, Participants with Meningiomas, Participants with Primary Gliomas, Participants with Radiation Necrosis, Participants with Tumor Recurrence |
Primary outcome
Comparison of T1 relaxation times
Time frame: Within the total 30-45 minute scan time
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by the 3D-MRF T1 relaxation times. The difference in mean T1 between each cohort of participants will be measured.
Comparison of T2 relaxation times
Time frame: Within the total 30-45 minute scan time
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by the 3D-MRF T2 relaxation times. The difference in mean T2 between each cohort of participants will be measured.
Comparison of proton density maps
Time frame: Within the total 30-45 minute scan time
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the MRF proton density maps of each cohort of participants. This will be compared using a t-test.
Comparison of water diffusion in brain tissues
Time frame: Within the total 30-45 minute scan time
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the diffusion parameters measured by the IVIM method between the three cohorts of participants. This will be compared using a t-test.
Comparison of blood perfusion in brain tissues
Time frame: Within the total 30-45 minute scan time
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the perfusion parameters measured by the IVIM method between the three cohorts of participants. This will be compared using a t-test.
Comparison of MRF imaging tool in different participant populations
Time frame: Within the total 30-45 minute scan time
The objective is to compare the effects of radiation dose on development of radiation and necrosis and tumor recurrence by comparing participants in all cohorts (healthy participants with no brain disease, participants with brain tumors (treated), participants with brain metastases or primary gliomas (previously untreated)). The predictive ability will be assessed by comparing univariable ROC analysis, quantified using area under the curve (AUC).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Lan Lu, PhD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Samuel Chao, MD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRF in conjunction with IVIM MRI without contrast in people with Brain Tumor and Brain Necrosis, run by Case Comprehensive Cancer Center at 2 sites 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 26 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lan Lu, PhD (1-866-223 8100, TaussigResearch@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of T1 relaxation times (time frame: Within the total 30-45 minute scan time). The study lists 6 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 20 Oct 2026.