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

Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05047965
• Other study ID #: 2012-0003
• Secondary ID: NCI-2019-0246120
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 25, 2013
• Est. completion date: February 2, 2027

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES:

I. Evaluate prospectively the accuracy of Dixon based sequences in detection of intraprostatic tumor nodules.

II. 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:

I. Compare the accuracy of Dixon based sequences versus multiparametric diffusion weighted imaging including diffusion tensor imaging in tumor detection and extraprostatic extension.

II. Compare the accuracy of Dixon based sequences in detection of transition zone tumors.

III. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Procedure:
• Dixon MRI
Undergo Dixon MRI
• Magnetic Resonance Imaging
Undergo standard MRI

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	Detection of at least one or more prostate lesions with Dixon sequencing	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.	through study completion, an average of 1 year

External Links

•   M D Anderson Cancer Center