Hematopoietic and Lymphoid Cell NeoplasmNCT03980535
New Magnetic Resonance Imaging and Spectroscopy Software in the Improvement of Image Quality
A study testing Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well new magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI) software works in improving the image quality of scans in both patients and healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2012to 21 Sep 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are scheduled for routine MR imaging or spectroscopy examinations at MD Anderson Cancer Center (MDACC).
- Written informed consent will be obtained from each subject scanned who enrolled to individual sub-project under this protocol.
- HEALTHY VOLUNTEERS: Written informed consent will be obtained from each subject scanned who enrolled to individual sub-project under this protocol
Who cannot join
- No pregnant subjects will be enrolled
- No one under 18 years of age will be enrolled
- No investigational devices or drugs will be used.
- No contraindications to MR exam(s)
- HEALTHY VOLUNTEERS: No pregnant subjects will be enrolled
- HEALTHY VOLUNTEERS: No one under 18 years of age will be enrolled
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- HEALTHY VOLUNTEERS: No investigational devices or drugs will be used
- HEALTHY VOLUNTEERS: No contraindications to MR exam(s) - healthy volunteers will use the same screening process utilized for MDACC patients (DI Patient Record - Part I, MR Screening Section)
- HEALTHY VOLUNTEERS: Healthy volunteers (including healthy MD Anderson employee volunteers) under the direct report of a sub-project principal investigator (PI) will be excluded for that specific sub-project.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of New Magnetic Resonance (MR) Imaging and Spectroscopy Software
This trial studies how well new magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI) software works in improving the image quality of scans in both patients and healthy volunteers. Improving the image quality of MRI and MRSI through new software may lead to implementation of these techniques and better clinical care for patients.
Read the detailed description
PRIMARY OBJECTIVE:
- To help develop and/or optimize new magnetic resonance (MR) imaging and spectroscopy applications and analysis software in order to provide the best MR services for our patients.
OUTLINE:
Patients undergo an additional investigational MRI or MRSI sequence along with the standard MRI or MRSI. Healthy volunteers undergo an investigational MRI or MRSI sequence. Healthy volunteers may also undergo an additional standard sequence if there is one that can be compared to the investigational sequence. All MRI or MRSI procedures, including the standard MRI or MRSI, are no longer than 60 minutes.
- Being tested
- Magnetic Resonance Imaging, Magnetic Resonance Spectroscopic Imaging
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI
Undergo MRI
Magnetic Resonance Spectroscopic ImagingProcedure or surgery
Also called 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS
Undergo MRSI
| Study group | Role | What they receive |
|---|---|---|
| Device Feasibility (MRI, MRSI) | Experimental | Patients undergo an additional investigational MRI or MRSI sequence along with the standard MRI or MRSI. Healthy volunteers undergo an investigational MRI or MRSI sequence. Healthy volunteers may also undergo an additional standard sequence if there is one that can be compared to the investigational sequence. All MRI or MRSI procedures, including the standard MRI or MRSI, are no longer than 60 minutes. Receives: Procedure: Magnetic Resonance Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development and/or optimization of new magnetic resonance (MR) imaging and spectroscopy applications and analysis software
A set of images will be collected using the new magnetic resonance imaging (MRI) or MR spectroscopy techniques. Whenever appropriate, another set of images using the standard of care software will also be collected and this set of images by the standard of care software will be compared to the images that are collected with the new MRI or MR spectroscopy techniques.
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start16 Apr 2012
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
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 Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- John Madewell, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980535
- Sponsor's protocol ID
- 2011-0542
- Other IDs
- NCI-2019-02654, 2011-0542
- Status last verified
- Oct 2022
- First submitted
- 6 Jun 2019
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Saleh M, Virarkar M, Javadi S, Mathew M, Vulasala SSR, Son JB, Sun J, Bayram E, Wang X, Ma J, Szklaruk J, Bhosale P. A Feasibility Study on Deep Learning Reconstruction to Improve Image Quality With PROPELLER Acquisition in the Setting of T2-Weighted Gynecologic Pelvic Magnetic Resonance Imaging. J Comput Assist Tomogr. 2023 Sep-Oct 01;47(5):721-728. doi: 10.1097/RCT.0000000000001491. Epub 2023 Jun 9.
PubMed 37707401
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Magnetic Resonance (MR) Imaging and Spectroscopy Software
- ClinicalTrials.gov ID
- NCT03980535
- Acronym / sponsor ID
- 2011-0542
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Apr 2012 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 10 Jun 2019 (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 studies how well new magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI) software works in improving the image quality of scans in both patients and healthy volunteers. Improving the image quality of MRI and MRSI through new software may lead to implementation of these techniques and better clinical care for patients.
Detailed description
PRIMARY OBJECTIVE:
- To help develop and/or optimize new magnetic resonance (MR) imaging and spectroscopy applications and analysis software in order to provide the best MR services for our patients.
OUTLINE:
Patients undergo an additional investigational MRI or MRSI sequence along with the standard MRI or MRSI. Healthy volunteers undergo an investigational MRI or MRSI sequence. Healthy volunteers may also undergo an additional standard sequence if there is one that can be compared to the investigational sequence. All MRI or MRSI procedures, including the standard MRI or MRSI, are no longer than 60 minutes.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Feasibility (MRI, MRSI) | Experimental | Procedure: Magnetic Resonance Imaging, Procedure: Magnetic Resonance Spectroscopic ImagingPatients undergo an additional investigational MRI or MRSI sequence along with the standard MRI or MRSI. Healthy volunteers undergo an investigational MRI or MRSI sequence. Healthy volunteers may also undergo an additional standard sequence if there is one that can be compared to the investigational sequence. All MRI or MRSI procedures, including the standard MRI or MRSI, are no longer than 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are scheduled for routine MR imaging or spectroscopy examinations at MD Anderson Cancer Center (MDACC).
- Written informed consent will be obtained from each subject scanned who enrolled to individual sub-project under this protocol.
- HEALTHY VOLUNTEERS: Written informed consent will be obtained from each subject scanned who enrolled to individual sub-project under this protocol
Key exclusion criteria (9 listed)
- No pregnant subjects will be enrolled
- No one under 18 years of age will be enrolled
- No investigational devices or drugs will be used.
- No contraindications to MR exam(s)
- HEALTHY VOLUNTEERS: No pregnant subjects will be enrolled
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 |
|---|---|---|
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRIUndergo MRI | Procedure or surgery | Device Feasibility (MRI, MRSI) |
| Magnetic Resonance Spectroscopic ImagingAlso: 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRSUndergo MRSI | Procedure or surgery | Device Feasibility (MRI, MRSI) |
Primary outcome
Development and/or optimization of new magnetic resonance (MR) imaging and spectroscopy applications and analysis software
Time frame: Up to 7 years
A set of images will be collected using the new magnetic resonance imaging (MRI) or MR spectroscopy techniques. Whenever appropriate, another set of images using the standard of care software will also be collected and this set of images by the standard of care software will be compared to the images that are collected with the new MRI or MR spectroscopy techniques.
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 28 Oct 2022.
- Derived from this study: PubMed 37707401Saleh M, Virarkar M, Javadi S, Mathew M, Vulasala SSR, Son JB, Sun J, Bayram E, Wang X, Ma J, Szklaruk J, Bhosale P. A Feasibility Study on Deep Learning Reconstruction to Improve Image Quality With PROPELLER Acquisition in the Setting of T2-Weighted Gynecologic Pelvic Magnetic Resonance Imaging. J Comput Assist Tomogr. 2023 Sep-Oct 01;47(5):721-728. doi: 10.1097/RCT.0000000000001491. Epub 2023 Jun 9.
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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.
John Madewell principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson 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 3 inclusion and 9 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 28 Oct 2022. 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?
Development and/or optimization of new magnetic resonance (MR) imaging and spectroscopy applications and analysis software (time frame: Up to 7 years). 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 NCT03980535, 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 28 Oct 2022.