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

Not Applicable

Completed

• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Interventions: Procedure: Magnetic Resonance Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging

• Registration Number: NCT03980535
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Detailed Description

PRIMARY OBJECTIVE:

I. 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 Timeline

• Study Start: 2012-04-16
• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Primary Completion: 2022-09-21
• Study Completion: 2022-09-21
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

• 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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device Feasibility (MRI, MRSI)	Magnetic Resonance Spectroscopic Imaging	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.
Device Feasibility (MRI, MRSI)	Magnetic Resonance Imaging	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.

Primary Outcome Measures

Name	Time	Method
Development and/or optimization of new magnetic resonance (MR) imaging and spectroscopy applications and analysis software	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States