New Magnetic Resonance Imaging and Spectroscopy Software in the Improvement of Image Quality

NCT03980535 | Completed FDA Device

• 2 other identifiers: 2011-0542NCI-2019-02654
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

Brief 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. Improving the image quality of MRI and MRSI through new software may lead to implementation of these techniques and better clinical care for patients.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 7 years

Study Arms (1)

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.

Procedure: Magnetic Resonance Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging

Interventions

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Device Feasibility (MRI, MRSI)

Magnetic Resonance Spectroscopic Imaging PROCEDURE

Undergo MRSI

Also known as: 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS, MRS Imaging, MRSI, Proton Magnetic Resonance Spectroscopic Imaging

Device Feasibility (MRI, MRSI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 37707401 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• John Madewell

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: April 16, 2012
• Primary Completion: September 21, 2022
• Study Completion: September 21, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

US (1)