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

Malignant Solid Neoplasm Clinical Trial

Official title:

Evaluation of New Magnetic Resonance (MR) Imaging and Spectroscopy Software

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980535
• Other study ID #: 2011-0542
• Secondary ID: NCI-2019-0265420
• Status: Completed
• Phase: N/A
• Start date: April 16, 2012
• Est. completion date: September 21, 2022

Study information

• Verified date: October 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: September 21, 2022
• Est. primary completion date: September 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Procedure:
• Magnetic Resonance Imaging
Undergo MRI
• Magnetic Resonance Spectroscopic Imaging
Undergo MRSI

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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