Myelodysplastic Syndrome (MDS)T2*MRINCT00749372
MRI Screening for Patients With Myelodysplastic Syndrome (MDS), Who Have Received Multiple Red Blood Cell Transfusions
A study testing T2* Cardiac and Liver MRI in people with Myelodysplastic Syndrome (MDS), run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
A known risk of red blood cell transfusions is that it puts excess iron into the patient's body. Researchers are continually seeking the most effective method of measuring iron concentration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome (MDS)
- What is being tested?
- T2* Cardiac and Liver MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2008to 29 Mar 2013
- 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
- Male or Female patients will need documentation of diagnosis of Myelodysplastic Syndrome by previous bone marrow exam
- Male or female patients with MDS who have received at least 50 units of Red Blood Cell Transfusions.
- Serum ferritin > 1,000
- Written informed consent by the patient.
Who cannot join
- Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Medical College of Cornell University
New York, New York, 10065
About this study
Official title: T2* Cardiac MRI Screening of Highly Transfused Patients With Myelodysplastic Syndrome
A known risk of red blood cell transfusions is that it puts excess iron into the patient's body. Researchers are continually seeking the most effective method of measuring iron concentration. The purpose of this study is to determine how much iron has been deposited in a patient's heart and liver as a result of having received red blood cell transfusions using magnetic resonance imaging (MRI).
- Conditions
- Myelodysplastic Syndrome (MDS)
- Being tested
- T2* Cardiac and Liver MRI
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T2* Cardiac and Liver MRIOther
Patients will undergo an MRI of the heart and liver.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Patients who meet eligibility will be sent for radiographic imaging to include T2* cardiac and liver MRI to ascertain quantification of organ-specific iron concentrations as well as cardiac left ventricular ejection fraction. Receives: Other: T2* Cardiac and Liver MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the incidence of clinically significant cardiac iron overload in heavily transfused MDS patients using T2* MRI.
Measured: A single T2* MRI will be performed on eligible patients.
Secondary outcomes (2)
Evaluate left ventricular ejection fraction as assessed by T2* MRI.
Measured: A single T2* MRI will be performed on eligible patients.
Evaluate liver iron concentration as assessed by R2* MRI
Measured: A single T2* MRI will be performed on eligible patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study start31 Jul 2008
- Primary completion29 Mar 2013
- Study completion29 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic Syndrome (MDS)Studies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Eric Feldman, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749372
- Sponsor's protocol ID
- 0803009687
- Other IDs
- CICL670A US23T
- Acronym
- T2*MRI
- Status last verified
- Oct 2018
- First submitted
- 8 Sep 2008
- Last updated
- 25 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T2* Cardiac MRI Screening of Highly Transfused Patients With Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT00749372
- Acronym / sponsor ID
- T2*MRI / 0803009687
- Conditions
- Myelodysplastic Syndrome (MDS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 31 Jul 2008 (actual)
- Primary completion
- 29 Mar 2013 (actual)
- Study completion
- 29 Mar 2013 (actual)
- First posted
- 9 Sep 2008 (estimated)
- 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.
A known risk of red blood cell transfusions is that it puts excess iron into the patient's body. Researchers are continually seeking the most effective method of measuring iron concentration. The purpose of this study is to determine how much iron has been deposited in a patient's heart and liver as a result of having received red blood cell transfusions using magnetic resonance imaging (MRI).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: T2* Cardiac and Liver MRIPatients who meet eligibility will be sent for radiographic imaging to include T2* cardiac and liver MRI to ascertain quantification of organ-specific iron concentrations as well as cardiac left ventricular ejection fraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female patients will need documentation of diagnosis of Myelodysplastic Syndrome by previous bone marrow exam
- Male or female patients with MDS who have received at least 50 units of Red Blood Cell Transfusions.
- Serum ferritin > 1,000
- Written informed consent by the patient.
Key exclusion criteria (1 listed)
- Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia.
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 |
|---|---|---|
| T2* Cardiac and Liver MRIPatients will undergo an MRI of the heart and liver. | Other | 1 |
Primary outcome
To evaluate the incidence of clinically significant cardiac iron overload in heavily transfused MDS patients using T2* MRI.
Time frame: A single T2* MRI will be performed on eligible patients.
2 secondary outcomes
Evaluate left ventricular ejection fraction as assessed by T2* MRI.
Time frame: A single T2* MRI will be performed on eligible patients.
Evaluate liver iron concentration as assessed by R2* MRI
Time frame: A single T2* MRI will be performed on eligible patients.
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 25 Oct 2018.
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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.
Eric Feldman, M.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T2* Cardiac and Liver MRI in people with Myelodysplastic Syndrome (MDS), run by Weill Medical College of Cornell University 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 1 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 25 Oct 2018. 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?
To evaluate the incidence of clinically significant cardiac iron overload in heavily transfused MDS patients using T2* MRI. (time frame: A single T2* MRI will be performed on eligible patients.). 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 25 Oct 2018.