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

Primary Purpose

Prostate Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dixon MRI
Magnetic Resonance Imaging
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.).

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (standard MRI, Dixon MRI)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2021
Last Updated
May 25, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05047965
Brief Title
An Investigational Scan (MRI With Dixon Based Sequences) in Detecting Prostate Cancer
Official Title
Evaluation of MRI With Dixon Based Sequences in the Detection of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 25, 2013 (Actual)
Primary Completion Date
February 2, 2027 (Anticipated)
Study Completion Date
February 2, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (standard MRI, Dixon MRI)
Arm Type
Experimental
Arm Description
Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes.
Intervention Type
Procedure
Intervention Name(s)
Dixon MRI
Other Intervention Name(s)
Dixon Fat-Suppression MRI
Intervention Description
Undergo Dixon MRI
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo standard MRI
Primary Outcome Measure Information:
Title
Detection of at least one or more prostate lesions with Dixon sequencing
Description
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.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ganeshan Dhakshina Moorthy
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

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

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