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

NCT05047965 | Active Not Recruiting Early Phase 1

• 2 other identifiers: 2012-0003NCI-2019-02461
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diagnostic (standard MRI, Dixon MRI)

EXPERIMENTAL

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

Procedure: Dixon MRI; Procedure: Magnetic Resonance Imaging

Interventions

Dixon MRI PROCEDURE

Undergo Dixon MRI

Also known as: Dixon Fat-Suppression MRI

Diagnostic (standard MRI, Dixon MRI)

Magnetic Resonance Imaging PROCEDURE

Undergo standard MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Diagnostic (standard MRI, Dixon MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Ganeshan Dhakshina Moorthy

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 17, 2021
• Study Start: April 25, 2013
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)