Clinical trial NCT03980535: New Magnetic Resonance Imaging and Spectroscopy Software in the Improvement of Image Quality
Official title: Evaluation of New Magnetic Resonance (MR) Imaging and Spectroscopy Software
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-06-10
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Development and/or optimization of new magnetic resonance (MR) imaging and spectroscopy applications and analysis software
timeFrame: Up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: John Madewell
role: PRINCIPAL_INVESTIGATOR
References: