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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status and phase

Active, not recruiting
Early Phase 1

Conditions

Prostate Carcinoma

Treatments

Procedure: Dixon MRI
Procedure: Magnetic Resonance Imaging

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05047965
NCI-2019-02461 (Registry Identifier)
2012-0003 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No 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.).

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

65 participants in 1 patient group

Diagnostic (standard MRI, Dixon MRI)
Experimental group
Description:
Patients undergo MRI with additional Dixon based sequences with fat and water over a total of 49 minutes.
Treatment:
Procedure: Magnetic Resonance Imaging
Procedure: Dixon MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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