SarcomaNCT00944476
Application of Magnetic Resonance Fat-Free Imaging
An observational study of Sarcoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Magnetic resonance imaging (MRI) is presently the best study for assessing the size and extent of the patient's sarcoma. Many sarcomas contain fat that can interfere with the accuracy of sarcoma detection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcoma
- What is being tested?
- Fat-free MRI images utilizing standard magnetization, Questionnaire before the MRI exam
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to May 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential research participants from those patients who are/will be scheduled for MRI examination as part of their routine clinical care at MSKCC. Dr. Singer will also identify four volunteers with no history of sarcoma to participate in this study.
Who may be able to join
- Participant is capable of providing verbal consent.
- 18 years of age or older.
- Participants will belong to one of the following two categories:
- Patient with a known or suspected soft tissue sarcoma of the extremity or trunk who is/will be scheduled for an MRI scan as part of their routine care, -OR--
- Volunteer with no history of sarcoma.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering CancerCenter
New York, New York, 10065
About this study
Magnetic resonance imaging (MRI) is presently the best study for assessing the size and extent of the patient's sarcoma. Many sarcomas contain fat that can interfere with the accuracy of sarcoma detection. The investigators have developed a new MRI method that can suppress all the fat signals in the patient's tumor and this may improve the investigators' ability to see the patient's sarcoma. The purpose of this study is to determine if the investigators' new fat-free imaging methods provides them with images that are better than, equal to, or worse than those images obtained by standard MRI methods. This study may help the investigators develop a more accurate MRI examination.
Read the detailed description
In addition, we will perform the same scans on 4 volunteers who have no history of sarcoma. Scanning volunteers will allow us to optimize the imaging technique by 1.) Determine the best combination of pulse-sequence and magnetization transfer technique to obtain the greatest contrast and 2.) Determine the parameters of repetition time (TR), echo time (TE) and magnetization transfer time and power in order to reduce overall image acquisition time while optimizing image quality. Honing this technique on volunteers will allow us to decrease scan time and potential discomfort for patients.
- Conditions
- Sarcoma
- Being tested
- Fat-free MRI images utilizing standard magnetization, Questionnaire before the MRI exam
- Keywords
- Sarcoma, soft tissue, MRI, Questionnaire, 09-078
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat-free MRI images utilizing standard magnetization, Questionnaire before the MRI examProcedure or surgery
In addition to the traditional MRI exam for clinical use, a fat-free MRI based on standard magnetization transfer magnetic resonance imaging will be acquired. Pts will spend 20 extra minutes and 20 minutes total for volunteers in the MRI scanner. Patients/volunteers will complete the MR Screening Questionnaire before the MRI exam.
| Study group | Role | What they receive |
|---|---|---|
| Pts/volunteers getting regular MRI exam | Fat-free MRI images utilizing standard magnetization transfer imaging will be acquired on 10 patients known or suspected sarcoma of the of the extremity or trunk, in addition to their traditional clinical MRI. In addition, we will perform the same scans on 4 volunteers who have no history of sarcoma. Receives: Procedure: Fat-free MRI images utilizing standard magnetization, Questionnaire before the MRI exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if our magnetization transfer fat-free imaging methods produce fat suppression images of sarcoma that are better, equal to or less in quality than fat-suppressed T2-weighted MRI images.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2014
Why it stopped: Software issues not resolved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Singer, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944476
- Sponsor's protocol ID
- 09-078
- Status last verified
- May 2014
- First submitted
- 22 Jul 2009
- Last updated
- 15 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Magnetic Resonance Fat-Free Imaging
- ClinicalTrials.gov ID
- NCT00944476
- Acronym / sponsor ID
- 09-078
- Conditions
- Sarcoma
- Keywords
- Sarcoma, soft tissue, MRI, Questionnaire, 09-078
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Software issues not resolved.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- May 2014 (actual)
- First posted
- 23 Jul 2009 (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.
Magnetic resonance imaging (MRI) is presently the best study for assessing the size and extent of the patient's sarcoma. Many sarcomas contain fat that can interfere with the accuracy of sarcoma detection. The investigators have developed a new MRI method that can suppress all the fat signals in the patient's tumor and this may improve the investigators' ability to see the patient's sarcoma. The purpose of this study is to determine if the investigators' new fat-free imaging methods provides them with images that are better than, equal to, or worse than those images obtained by standard MRI methods. This study may help the investigators develop a more accurate MRI examination.
Detailed description
In addition, we will perform the same scans on 4 volunteers who have no history of sarcoma. Scanning volunteers will allow us to optimize the imaging technique by 1.) Determine the best combination of pulse-sequence and magnetization transfer technique to obtain the greatest contrast and 2.) Determine the parameters of repetition time (TR), echo time (TE) and magnetization transfer time and power in order to reduce overall image acquisition time while optimizing image quality. Honing this technique on volunteers will allow us to decrease scan time and potential discomfort for patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pts/volunteers getting regular MRI exam | – | Procedure: Fat-free MRI images utilizing standard magnetization, Questionnaire before the MRI examFat-free MRI images utilizing standard magnetization transfer imaging will be acquired on 10 patients known or suspected sarcoma of the of the extremity or trunk, in addition to their traditional clinical MRI. In addition, we will perform the same scans on 4 volunteers who have no history of sarcoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential research participants from those patients who are/will be scheduled for MRI examination as part of their routine clinical care at MSKCC. Dr. Singer will also identify four volunteers with no history of sarcoma to participate in this study.
Key inclusion criteria (5 listed)
- Participant is capable of providing verbal consent.
- 18 years of age or older.
- Participants will belong to one of the following two categories:
- Patient with a known or suspected soft tissue sarcoma of the extremity or trunk who is/will be scheduled for an MRI scan as part of their routine care, -OR--
- Volunteer with no history of sarcoma.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Fat-free MRI images utilizing standard magnetization, Questionnaire before the MRI examIn addition to the traditional MRI exam for clinical use, a fat-free MRI based on standard magnetization transfer magnetic resonance imaging will be acquired. Pts will spend 20 extra minutes and 20 minutes total for volunteers in the MRI scanner. Patients/volunteers will complete the MR Screening Questionnaire before the MRI exam. | Procedure or surgery | Pts/volunteers getting regular MRI exam |
Primary outcome
To determine if our magnetization transfer fat-free imaging methods produce fat suppression images of sarcoma that are better, equal to or less in quality than fat-suppressed T2-weighted MRI images.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Software issues not resolved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Samuel Singer, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Sarcoma, run by Memorial Sloan Kettering Cancer Center 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 5 inclusion and 0 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: stopped early, as of the sponsor's last update on 15 May 2014. 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 was stopped early (reason given: Software issues not resolved.). Results are not available in the source record.
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 determine if our magnetization transfer fat-free imaging methods produce fat suppression images of sarcoma that are better, equal to or less in quality than fat-suppressed T2-weighted MRI images. (time frame: 2 years). 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 15 May 2014.