An Investigational Scan (MRI With Dixon Based Sequences) in Detecting Prostate Cancer

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05047965

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

116.2

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial studies the use of magnetic resonance imaging (MRI) with Dixon based imaging sequences in detecting prostate cancer. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. Researchers hope to learn if using a modified MRI scan technique with Dixon based imaging sequencing will help to produce better images of prostate cancer than the standard of care MRI scan technique.

Condition or Disease	Intervention/Treatment	Phase
Prostate Carcinoma	Procedure: Dixon MRI Procedure: Magnetic Resonance Imaging	N/A

Detailed Description

PRIMARY OBJECTIVES:

Evaluate prospectively the accuracy of Dixon based sequences in detection of intraprostatic tumor nodules.
Determine the sensitivity, specificity, positive and negative predictive value of Dixon based sequences in assessment of extraprostatic tumor extension and lymph node involvement.

SECONDARY OBJECTIVES:

Compare the accuracy of Dixon based sequences versus multiparametric diffusion weighted imaging including diffusion tensor imaging in tumor detection and extraprostatic extension.
Compare the accuracy of Dixon based sequences in detection of transition zone tumors.
Determine the optimal scanning parameters for Dixon based sequences in the imaging of prostate adenocarcinoma.

OUTLINE:

Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of MRI With Dixon Based Sequences in the Detection of Prostate Cancer

Actual Study Start Date :

Apr 25, 2013

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diagnostic (standard MRI, Dixon MRI) Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes.	Procedure: Dixon MRI Undergo Dixon MRI Other Names: Dixon Fat-Suppression MRI Procedure: Magnetic Resonance Imaging Undergo standard MRI Other Names: Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging

Arm

Intervention/Treatment

Experimental: Diagnostic (standard MRI, Dixon MRI)

Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes.

Procedure: Dixon MRI

Undergo Dixon MRI

Other Names:

Dixon Fat-Suppression MRI

Procedure: Magnetic Resonance Imaging

Undergo standard MRI

Other Names:

Magnetic Resonance Imaging Scan

Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

MR Imaging

MRI

MRI Scan

NMR Imaging

NMRI

Nuclear Magnetic Resonance Imaging

Outcome Measures

Primary Outcome Measures

Detection of at least one or more prostate lesions with Dixon sequencing [through study completion, an average of 1 year]
Will evaluate and compare the accuracy of Dixon based sequencing to the conventional T2 weighted sequencing for detection of intraprostatic tumor and extraprostatic tumor extension. Lesions will be within any of six regions of the prostate: left apex, left mid, left base, right apex, right mid, and right base. The relative sensitivity and specificity of the two sequencing methods will be compared using an adjusted McNemar's test for clustered data where clusters consist of the matched pairs of within patient-zone observations. The primary analysis will also provide 95% confidence intervals for marginal sensitivity and specificity using a generalized linear mixed model.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Biopsy proven prostate cancer patients who are scheduled to undergo prostatectomy.
Patient who is scheduled to have a clinically indicated staging endorectal prostate MRI exam.
Patients who have signed their informed consent form to undergo the study.

Exclusion Criteria:

Known prior hormone ablation or radiation therapy (pelvic or prostate).
Patients who do not want to undergo prostatectomy and prefer other therapy or surveillance.
Contraindication to conventional MR imaging (e. g. metal implants, pace maker, etc.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators

Principal Investigator: Vikas Kundra, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

M D Anderson Cancer Center

Publications

None provided.

Responsible Party:

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT05047965

Other Study ID Numbers:

2012-0003
NCI-2019-02461
2012-0003

First Posted:

Sep 17, 2021

Last Update Posted:

Sep 17, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Sep 17, 2021