Sickle Cell DiseaseNCT03458897
Quantitative MRI for Patients With Sickle Cell Disease Undergoing Hematopoietic Cell Transplant
A study testing serial functional magnetic resonance imaging (MRI) in people with Sickle Cell Disease, run by University of Michigan at 1 site in United States.
Trial summary
The primary purpose of this research is to determine if it is feasible to perform serial magnetic resonance imaging (MRI) to evaluate the amount of bone marrow cells (also called cellularity) and iron stores before and after bone marrow transplantation for severe sickle cell disease. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- serial functional magnetic resonance imaging (MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2018to 1 Sep 2020
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 5 years.
- Diagnosis of SCD ([Hemoglobin SS (Hb-SS), Hemoglobin SC (Hb-SC) or Hemoglobin S-Beta thalassemia (Hb-Sβ) genotype].
- Patient is a candidate for an allogeneic HCT.
- Subject or guardians have given informed consent.
Who cannot join
- The need for general anesthesia for MRI.
- Subjects with implanted magnetic devices (e.g. pacemakers) that may malfunction or move in the strong magnetic field.
- A subject who is pregnant.
- Previous HCT.
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of this research is to determine if it is feasible to perform serial magnetic resonance imaging (MRI) to evaluate the amount of bone marrow cells (also called cellularity) and iron stores before and after bone marrow transplantation for severe sickle cell disease.
- Conditions
- Sickle Cell Disease
- Being tested
- serial functional magnetic resonance imaging (MRI)
- Keywords
- bone marrow cellularity, bone marrow transplant
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serial functional magnetic resonance imaging (MRI)Diagnostic test
All subjects with sickle cell disease undergoing bone marrow transplantation will undergo up to 4 functional MRI scans.
| Study group | Role | What they receive |
|---|---|---|
| MRI arm | Experimental | Subjects with sickle cell disease undergoing bone marrow transplantation will undergo serial functional MRI (up to 4 scans). Receives: Diagnostic Test: serial functional magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of obtaining serial scans in patients with sickle cell undergoing marrow transplant
Feasibility will be measured by the number of subjects who undergo at least 2 of 4 scheduled functional MRI's
Measured: 110 days post transplant
Secondary outcomes (3)
MRI and hemoglobin S.
Correlation between functional MRI result and hemoglobin S level.
Measured: 1 year post transplant
MRI and neutrophil engraftment
Correlation between functional MRI result and time to neutrophil engraftment
Measured: 1 year post transplant
MRI and chimerism
Correlation between functional MRI result and time to donor/ recipient chimerism
Measured: 1 year post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start3 May 2018
- Primary completion16 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Abusin, University of Michigan
- Investigators
- Ghada Abusin, MBBS MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458897
- Sponsor's protocol ID
- HUM00132776
- Status last verified
- Nov 2020
- First submitted
- 2 Mar 2018
- Last updated
- 13 Nov 2020
- Results posted
- No
- 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative MRI for Patients With Sickle Cell Disease Undergoing Hematopoietic Cell Transplant
- ClinicalTrials.gov ID
- NCT03458897
- Acronym / sponsor ID
- HUM00132776
- Conditions
- Sickle Cell Disease
- Keywords
- bone marrow cellularity, bone marrow transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 16 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 8 Mar 2018 (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 primary purpose of this research is to determine if it is feasible to perform serial magnetic resonance imaging (MRI) to evaluate the amount of bone marrow cells (also called cellularity) and iron stores before and after bone marrow transplantation for severe sickle cell disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI arm | Experimental | Diagnostic Test: serial functional magnetic resonance imaging (MRI)Subjects with sickle cell disease undergoing bone marrow transplantation will undergo serial functional MRI (up to 4 scans). |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 5 years.
- Diagnosis of SCD ([Hemoglobin SS (Hb-SS), Hemoglobin SC (Hb-SC) or Hemoglobin S-Beta thalassemia (Hb-Sβ) genotype].
- Patient is a candidate for an allogeneic HCT.
- Subject or guardians have given informed consent.
Key exclusion criteria (4 listed)
- The need for general anesthesia for MRI.
- Subjects with implanted magnetic devices (e.g. pacemakers) that may malfunction or move in the strong magnetic field.
- A subject who is pregnant.
- Previous HCT.
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 |
|---|---|---|
| serial functional magnetic resonance imaging (MRI)All subjects with sickle cell disease undergoing bone marrow transplantation will undergo up to 4 functional MRI scans. | Diagnostic test | MRI arm |
Primary outcome
Feasibility of obtaining serial scans in patients with sickle cell undergoing marrow transplant
Time frame: 110 days post transplant
Feasibility will be measured by the number of subjects who undergo at least 2 of 4 scheduled functional MRI's
3 secondary outcomes
MRI and hemoglobin S.
Time frame: 1 year post transplant
MRI and neutrophil engraftment
Time frame: 1 year post transplant
MRI and chimerism
Time frame: 1 year post transplant
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 13 Nov 2020.
- 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. This study is not recruiting at the moment.
Ghada Abusin, MBBS MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serial functional magnetic resonance imaging (MRI) in people with Sickle Cell Disease, run by University of Michigan 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 4 inclusion and 4 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 13 Nov 2020. 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?
Feasibility of obtaining serial scans in patients with sickle cell undergoing marrow transplant (time frame: 110 days post transplant). 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 13 Nov 2020.