Cerebrovascular DisordersNCT03266848
Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI
An observational study of Cerebrovascular Disorders, run by Theranano LLC at 1 site in United States.
Trial summary
This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the method with first-in-human studies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrovascular Disorders
- What is being tested?
- Quantitative Magnetic Resonance Imaging
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2017to 22 Jul 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with iron deficiency anemia already scheduled to receive ferumoxytol infusion for iron replacement therapy.
Who may be able to join
- Between the ages of 18 to 80;
- Able to understand written consent document and HIPAA authorization prior to initiation of study related procedures.
Who cannot join
- Known allergy to ferumoxytol or any intravenous iron preparation;
- Iron saturation above the upper limit of normal;
- Individuals with a contraindication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator);
- Individuals with known clinical conditions that may lead to iron overload including hemochromatosis, cirrhosis, or sickle cell disease;
- Individuals with any serious medical condition that the investigator believes may place them at increased risk for an adverse event.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the method with first-in-human studies.
Read the detailed description
This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI using Ferumoxytol as a contrast agent, and validate the method with first-in-human studies. Subjects who are already scheduled to receive ferumoxytol infusion will undergo MRI scans after the infusion. The ferumoxytol infusion itself is not a part of the study. The project will provide brain angiograms and establish a human cerebrovascular atlas that will enable future quantitative diagnosis of cerebrovascular abnormalities by revealing abnormal regions of the brain that characterize disease, a tool which doesn't currently exist, and which could lead to many exciting discoveries and clinical applications in neurology.
- Conditions
- Cerebrovascular Disorders
- Being tested
- Quantitative Magnetic Resonance Imaging
- Keywords
- Magnetic Resonance Imaging, Ferumoxytol
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Magnetic Resonance ImagingDiagnostic test
Radiological diagnosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular Angiography
Obtain angiograms of the cerebral vasculature from the MRI intensity data
Measured: 0-4 hours after ferumoxytol infusion
Secondary outcomes (1)
Quantitative cerebral blood volume atlas
Create cerebral blood volume atlas from the quantitative MRI intensity data
Measured: 0-4 hours after ferumoxytol infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start8 Nov 2017
- Primary completion22 Jul 2020
- Study completion22 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranano LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Northeastern University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Srinivas Sridhar, Ph.D., Principal investigator, Theranano LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266848
- Sponsor's protocol ID
- R41DA043974
- Other IDs
- R41DA043974
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2017
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Timms L, Zhou T, Qiao J, Gharagouzloo C, Mishra V, Lahoud RM, Chen JW, Harisinghani M, Sridhar S. Super High Contrast USPIO-Enhanced Cerebrovascular Angiography Using Ultrashort Time-to-Echo MRI. Int J Biomed Imaging. 2024 Apr 13;2024:9763364. doi: 10.1155/2024/9763364. eCollection 2024.
PubMed 38644981
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI
- ClinicalTrials.gov ID
- NCT03266848
- Acronym / sponsor ID
- R41DA043974
- Conditions
- Cerebrovascular Disorders
- Keywords
- Magnetic Resonance Imaging, Ferumoxytol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Theranano LLCIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Northeastern University, National Institute on Drug Abuse (NIDA)
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 22 Jul 2020 (actual)
- Study completion
- 22 Jul 2020 (actual)
- First posted
- 30 Aug 2017 (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 will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the method with first-in-human studies.
Detailed description
This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI using Ferumoxytol as a contrast agent, and validate the method with first-in-human studies. Subjects who are already scheduled to receive ferumoxytol infusion will undergo MRI scans after the infusion. The ferumoxytol infusion itself is not a part of the study. The project will provide brain angiograms and establish a human cerebrovascular atlas that will enable future quantitative diagnosis of cerebrovascular abnormalities by revealing abnormal regions of the brain that characterize disease, a tool which doesn't currently exist, and which could lead to many exciting discoveries and clinical applications in neurology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with iron deficiency anemia already scheduled to receive ferumoxytol infusion for iron replacement therapy.
Key inclusion criteria (2 listed)
- Between the ages of 18 to 80;
- Able to understand written consent document and HIPAA authorization prior to initiation of study related procedures.
Key exclusion criteria (5 listed)
- Known allergy to ferumoxytol or any intravenous iron preparation;
- Iron saturation above the upper limit of normal;
- Individuals with a contraindication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator);
- Individuals with known clinical conditions that may lead to iron overload including hemochromatosis, cirrhosis, or sickle cell disease;
- Individuals with any serious medical condition that the investigator believes may place them at increased risk for an adverse event.
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 |
|---|---|---|
| Quantitative Magnetic Resonance ImagingRadiological diagnosis | Diagnostic test | – |
Primary outcome
Cerebrovascular Angiography
Time frame: 0-4 hours after ferumoxytol infusion
Obtain angiograms of the cerebral vasculature from the MRI intensity data
1 secondary outcome
Quantitative cerebral blood volume atlas
Time frame: 0-4 hours after ferumoxytol infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Derived from this study: PubMed 38644981Timms L, Zhou T, Qiao J, Gharagouzloo C, Mishra V, Lahoud RM, Chen JW, Harisinghani M, Sridhar S. Super High Contrast USPIO-Enhanced Cerebrovascular Angiography Using Ultrashort Time-to-Echo MRI. Int J Biomed Imaging. 2024 Apr 13;2024:9763364. doi: 10.1155/2024/9763364. eCollection 2024.
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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.
Srinivas Sridhar, Ph.D. principal investigator
Theranano LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Disorders, run by Theranano LLC 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 2 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: finished, as of the sponsor's last update on 24 Aug 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cerebrovascular Angiography (time frame: 0-4 hours after ferumoxytol infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03266848, which also lists 1 linked publication.
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 24 Aug 2021.