Intracranial Vascular DiseaseNCT05505071
DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease
A study testing DANTE SPACE sequence in people with Intracranial Vascular Disease, run by University of North Carolina, Chapel Hill.
Trial summary
Purpose: The purpose of this study is to evaluate the Delay Alternating with Nutation for Tailored Excitation (DANTE) SPACE sequence in clinical studies to determine whether it can provide more useful information for clinical diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Vascular Disease
- What is being tested?
- DANTE SPACE sequence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 and older
- Concern for intracranial vascular disease
- Scheduled to undergo a clinical vessel wall MRI
Who cannot join
- Claustrophobia
- Implanted metallic devices, parts, vascular clips, or other foreign bodies.
- Known hypersensitivity to gadolinium contrast or to any component of gadolinium contrast refractory to standard medications (antihistamines, steroids)
- Impaired kidney function (serum creatinine level > 1.8 mg/dL or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
- Any woman who is pregnant or has reason to believe she is pregnant via self report
About this study
Purpose: The purpose of this study is to evaluate the Delay Alternating with Nutation for Tailored Excitation (DANTE) SPACE sequence in clinical studies to determine whether it can provide more useful information for clinical diagnosis.
Participants: 100 participants with concern for intracranial vascular disease scheduled to undergo a clinical vessel wall MRI will be recruited.
Procedures (methods): Patients with concern for intracranial vascular disease scheduled to undergo a clinical vessel wall MRI who will have an additional non-FDA approved sequence (DANTE SPACE) added to their clinical scan. The investigational sequence requires less than 15 minutes and will be added following the standard MRI sequence.
- Conditions
- Intracranial Vascular Disease
- Being tested
- DANTE SPACE sequence
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DANTE SPACE sequenceDevice
Also called Delay Alternating with Nutation for Tailored Excitation (DANTE)
investigational MRI sequence less than 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| DANTE SPACE MRI Sequence | Experimental | Participants will receive an additional DANTE SPACE sequence with their clinical MRI Receives: Device: DANTE SPACE sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Utility for Visualizing Pathology
The primary objective is to determine the percent of participants with a visible region of interest.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: PI leaving institution and study will not be started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmud Mossa-Basha, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505071
- Sponsor's protocol ID
- 22-2096
- Status last verified
- Dec 2022
- First submitted
- 15 Aug 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease
- ClinicalTrials.gov ID
- NCT05505071
- Acronym / sponsor ID
- 22-2096
- Conditions
- Intracranial Vascular Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI leaving institution and study will not be started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Aug 2022 (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.
Purpose: The purpose of this study is to evaluate the Delay Alternating with Nutation for Tailored Excitation (DANTE) SPACE sequence in clinical studies to determine whether it can provide more useful information for clinical diagnosis.
Participants: 100 participants with concern for intracranial vascular disease scheduled to undergo a clinical vessel wall MRI will be recruited.
Procedures (methods): Patients with concern for intracranial vascular disease scheduled to undergo a clinical vessel wall MRI who will have an additional non-FDA approved sequence (DANTE SPACE) added to their clinical scan. The investigational sequence requires less than 15 minutes and will be added following the standard MRI sequence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DANTE SPACE MRI Sequence | Experimental | Device: DANTE SPACE sequenceParticipants will receive an additional DANTE SPACE sequence with their clinical MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18 and older
- Concern for intracranial vascular disease
- Scheduled to undergo a clinical vessel wall MRI
Key exclusion criteria (5 listed)
- Claustrophobia
- Implanted metallic devices, parts, vascular clips, or other foreign bodies.
- Known hypersensitivity to gadolinium contrast or to any component of gadolinium contrast refractory to standard medications (antihistamines, steroids)
- Impaired kidney function (serum creatinine level > 1.8 mg/dL or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
- Any woman who is pregnant or has reason to believe she is pregnant via self report
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 |
|---|---|---|
| DANTE SPACE sequenceAlso: Delay Alternating with Nutation for Tailored Excitation (DANTE)investigational MRI sequence less than 15 minutes | Device | DANTE SPACE MRI Sequence |
Primary outcome
Clinical Utility for Visualizing Pathology
Time frame: Baseline
The primary objective is to determine the percent of participants with a visible region of interest.
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 5 Jan 2023.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
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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.
Mahmud Mossa-Basha, MD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A study testing DANTE SPACE sequence in people with Intracranial Vascular Disease, run by University of North Carolina, Chapel Hill.
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 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 5 Jan 2023. 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?
Clinical Utility for Visualizing Pathology (time frame: Baseline). 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 5 Jan 2023.