ImageNCT06127810
MRI Gadopiclenol Enhanced Imaging of CNS Tumors
An observational study of Image, run by Medical University of South Carolina.
Trial summary
The purpose of this pilot study is to compare a standard of care MRI scan to a non-standard of care MR imaging with portable (0.064 Tesla) MRI following the administration of non-SOC contrast called Gadopiclenol on 10 subjects with known brain tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Image
- What is being tested?
- CE MRI on 0.064T Scanner and Gadopiclenol
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 30 Dec 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient presenting, at the time of inclusion, with known or highly suspected focal areas of disrupted Blood Brain Barrier (BBB) due to primary or secondary tumor/s.
Who may be able to join
- Female or male adult patient (18 years and older).
- Patient presenting, at the time of inclusion, with known or highly suspected focal areas of disrupted Blood Brain Barrier (BBB) due to primary or secondary tumor/s. This lesion must have been detected on a previous imaging procedure (computerized Tomography (CT) or MRI).
- Patient scheduled for a routine CNS contrast-enhanced MRI examination for clinical reasons.
- Patient able and willing to participate in the study.
- Patient with health insurance.
Who cannot join
- Patient presenting with acute or chronic Grade III (at least) renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m² based on eGFR assessment on the day of each MRI.
- Pregnant or breast-feeding female patient (a female patient of childbearing potential must be using a medically approved contraception method until the last study visit).
- Patient with any contraindication to MRI examinations including active implants, passive implants which are MRI incompatible, and metallic foreign bodies.
- Patient with known contra-indication(s) to the use or with known sensitivity to any GBCA.
- Patient having received any contrast agent (MRI or CT) within 3 days prior to study gadopiclenol administration
About this study
Official title: A Pilot Study of Gadopiclenol for Imaging Central Nervous System (CNS) Tumors at Point of Care Magnetic Resonance Imaging (MRI)
The purpose of this pilot study is to compare a standard of care MRI scan to a non-standard of care MR imaging with portable (0.064 Tesla) MRI following the administration of non-SOC contrast called Gadopiclenol on 10 subjects with known brain tumors.
Participants will be randomized to receive either standard MRI or portable MRI first following contrast injection
Read the detailed description
This study compares a routine MRI scan with a new portable MRI scanner known as the "Hyperfine" using a contrast dye called Gadopiclenol, the contrast is FDA approved. If participants choose to participate in this study, they will receive two MRI scans on the same day. One on the traditional standard of care MRI scanner and the other on the new portable Hyperfine MRI. The Hyperfine MRI scanner is not FDA approved due to being a very low risk medical device. However, the device is compliant with all of the FDA requirements regarding design control regulations and risk analysis. Participants will only receive one contrast injection that will be used for both scans. The selection of which scan is given first will be randomly selected (50/50 chance). Participation in this study will last two days. The first day participants will receive both MRI scans and the second day participants will receive a phone call from the research staff to check on them.
- Conditions
- Image
- Being tested
- CE MRI on 0.064T Scanner, Gadopiclenol
- Keywords
- MRI, Radiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CE MRI on 0.064T ScannerDevice
Pt will undergo contrast enhanced images using Gadopiclenol on Hyperfine MRI
GadopiclenolDrug
Subjects will receive Gadopiclenol instead of standard of care contrast
| Study group | Role | What they receive |
|---|---|---|
| 3T Contrast Enhanced Images First | Not described Receives: Device: CE MRI on 0.064T Scanner; Drug: Gadopiclenol | |
| 0.064 Contrast Enhanced Images First | Not described Receives: Device: CE MRI on 0.064T Scanner; Drug: Gadopiclenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visibility of lesions
Visibility of lesions and diagnostic capabilities of 0.068T MRI
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start30 Dec 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Why it stopped: The sponsor backed out of the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImageStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127810
- Sponsor's protocol ID
- Pro00129735
- Status last verified
- Jan 2025
- First submitted
- 30 Oct 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Gadopiclenol for Imaging Central Nervous System (CNS) Tumors at Point of Care Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT06127810
- Acronym / sponsor ID
- Pro00129735
- Conditions
- Image
- Keywords
- MRI, Radiology
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The sponsor backed out of the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Guerbet
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 13 Nov 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 pilot study is to compare a standard of care MRI scan to a non-standard of care MR imaging with portable (0.064 Tesla) MRI following the administration of non-SOC contrast called Gadopiclenol on 10 subjects with known brain tumors.
Participants will be randomized to receive either standard MRI or portable MRI first following contrast injection
Detailed description
This study compares a routine MRI scan with a new portable MRI scanner known as the "Hyperfine" using a contrast dye called Gadopiclenol, the contrast is FDA approved. If participants choose to participate in this study, they will receive two MRI scans on the same day. One on the traditional standard of care MRI scanner and the other on the new portable Hyperfine MRI. The Hyperfine MRI scanner is not FDA approved due to being a very low risk medical device. However, the device is compliant with all of the FDA requirements regarding design control regulations and risk analysis. Participants will only receive one contrast injection that will be used for both scans. The selection of which scan is given first will be randomly selected (50/50 chance). Participation in this study will last two days. The first day participants will receive both MRI scans and the second day participants will receive a phone call from the research staff to check on them.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3T Contrast Enhanced Images First | – | Device: CE MRI on 0.064T Scanner, Drug: Gadopiclenol |
| 0.064 Contrast Enhanced Images First | – | Device: CE MRI on 0.064T Scanner, Drug: Gadopiclenol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient presenting, at the time of inclusion, with known or highly suspected focal areas of disrupted Blood Brain Barrier (BBB) due to primary or secondary tumor/s.
Key inclusion criteria (5 listed)
- Female or male adult patient (18 years and older).
- Patient presenting, at the time of inclusion, with known or highly suspected focal areas of disrupted Blood Brain Barrier (BBB) due to primary or secondary tumor/s. This lesion must have been detected on a previous imaging procedure (computerized Tomography (CT) or MRI).
- Patient scheduled for a routine CNS contrast-enhanced MRI examination for clinical reasons.
- Patient able and willing to participate in the study.
- Patient with health insurance.
Key exclusion criteria (5 listed)
- Patient presenting with acute or chronic Grade III (at least) renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m² based on eGFR assessment on the day of each MRI.
- Pregnant or breast-feeding female patient (a female patient of childbearing potential must be using a medically approved contraception method until the last study visit).
- Patient with any contraindication to MRI examinations including active implants, passive implants which are MRI incompatible, and metallic foreign bodies.
- Patient with known contra-indication(s) to the use or with known sensitivity to any GBCA.
- Patient having received any contrast agent (MRI or CT) within 3 days prior to study gadopiclenol administration
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 |
|---|---|---|
| CE MRI on 0.064T ScannerPt will undergo contrast enhanced images using Gadopiclenol on Hyperfine MRI | Device | 0.064 Contrast Enhanced Images First, 3T Contrast Enhanced Images First |
| GadopiclenolSubjects will receive Gadopiclenol instead of standard of care contrast | Drug | 0.064 Contrast Enhanced Images First, 3T Contrast Enhanced Images First |
Primary outcome
Visibility of lesions
Time frame: 1 Day
Visibility of lesions and diagnostic capabilities of 0.068T MRI
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Image, run by Medical University of South Carolina.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Visibility of lesions (time frame: 1 Day). 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 4 Feb 2025.