Dixon MRI for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Hormone ablation, Radiation therapy, Metal implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for using MRI scans to better detect prostate cancer. Researchers are testing a modified MRI technique, called Dixon imaging, to determine if it provides clearer images of prostate cancer compared to traditional MRI scans. This technique is intended for men with confirmed prostate cancer who are scheduled for surgery and a specific type of MRI exam. The goal is to improve how doctors identify and understand prostate cancer. As an Early Phase 1 trial, this research focuses on understanding how this new imaging technique works in people, offering participants a chance to contribute to groundbreaking advancements in prostate cancer detection.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this MRI technique is safe for detecting prostate cancer?

Research has shown that the Dixon MRI technique can enhance image clarity by reducing the appearance of fat in the body, which is crucial for obtaining better images when assessing prostate cancer. Although no specific reports of side effects from using the Dixon MRI exist, MRI itself remains a safe and common procedure. It employs a magnet and radio waves to create detailed images of the body's interior.

As this trial is in its early stages, specific safety data is limited. However, studies using Dixon MRI so far have shown promise in improving image quality without known issues. MRI exams, in general, are well-tolerated and do not involve radiation, making them a low-risk option for imaging.

Participants should consult the trial team or their doctor with any questions about safety or concerns about participating. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Dixon MRI technique for prostate cancer because it introduces a new imaging method that may provide clearer, more detailed images compared to standard MRI scans. Unlike traditional MRIs, Dixon MRI sequences separate fat and water signals, which can enhance the visibility of prostate tumors and potentially improve diagnostic accuracy. This approach could lead to earlier and more precise detection of prostate cancer, which is crucial for effective treatment planning and better patient outcomes.

What evidence suggests that Dixon MRI is effective for detecting prostate cancer?

Research has shown that Dixon MRI, which participants in this trial will undergo alongside standard MRI, might excel at detecting prostate cancer. Studies have found that Dixon MRI can accurately identify cancerous areas due to its superior detection capabilities. In one study, Dixon MRI demonstrated an accuracy of about 86.6% to 87.2% in diagnosing prostate cancer, surpassing standard MRI methods. Another study found that Dixon MRI effectively distinguished between non-cancerous and cancerous areas. These promising results suggest that Dixon MRI might enhance prostate cancer detection compared to traditional methods. ^{6 7 8 9 10}

Who Is on the Research Team?

Ganeshan Dhakshina Moorthy

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for men with biopsy-proven prostate cancer who have consented to participate, are scheduled for prostate removal surgery (prostatectomy), and a standard MRI scan. It's not open to those who've had hormone or radiation therapy affecting the pelvis or prostate, prefer other treatments over surgery, or can't have MRIs due to metal implants or pacemakers.

Inclusion Criteria

I have prostate cancer confirmed by biopsy and will have surgery to remove my prostate.

Patients who have signed their informed consent form to undergo the study

I am scheduled for a prostate MRI to check the cancer stage.

Exclusion Criteria

Contraindication to conventional MR imaging (e.g. metal implants, pacemaker, etc.)

I have had hormone therapy or radiation for my pelvic or prostate area.

I prefer not to have surgery for my prostate condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

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

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dixon MRI

Trial Overview The study is testing whether a modified MRI technique using Dixon based imaging sequences can provide better images of prostate cancer compared to the usual MRI scans. The goal is to see if this new scanning method improves the detection and visualization of prostate tumors.

How Is the Trial Designed?

Group I: Diagnostic (standard MRI, Dixon MRI) Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 122 men with Gleason 6 prostate cancer, transrectal prostate biopsy was found to have a significantly greater temporary negative impact on quality of life compared to prostate multiparametric MRI (mpMRI), with quality of life scores of 0.82 versus 0.95, respectively.

The most notable difference in health impact was related to intraprocedural pain, where biopsy patients reported much higher pain levels than those undergoing mpMRI, indicating that mpMRI may be a safer and less painful option for monitoring prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary Health Impact of Prostate MRI and Transrectal Prostate Biopsy in Active Surveillance Prostate Cancer Patients. Shankar, PR., Maturen, KE., George, AK., et al.[2020]

Magnetic resonance imaging (MRI) is becoming increasingly important for diagnosing prostate cancer due to its high resolution, which allows for effective detection, localization, and evaluation of cancer spread beyond the prostate.

MRI is recommended by clinical guidelines for patients with at least one negative biopsy, and it is particularly useful for staging advanced tumors (cT3/4) or those with a high Gleason score (≥8), enhancing the accuracy of targeted biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prostate cancer]. Franiel, T., Eckardt, N., Waginger, M., et al.[2022]

MRI is becoming increasingly important for diagnosing and monitoring prostate cancer, with ongoing research aimed at identifying specific imaging characteristics that enhance its effectiveness.

The article discusses the Prostate Imaging Reporting and Data System (PI-RADS), a standardized scoring and reporting system that helps radiologists evaluate prostate MRI results, particularly for patients with varying biopsy histories and PSA levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging for prostate cancer: what the urologist needs to know. Kiechle, J., Pahwa, S., Gulani, V., et al.[2017]

Magnetic resonance imaging (MRI) has a significant diagnostic performance for detecting prostate cancer in patients with prior negative biopsies and elevated PSA levels, with a mean detection rate of 37.5% across 14 studies involving 698 patients.

MRI combined with magnetic resonance spectroscopy imaging (MRSI) shows the highest accuracy, achieving a pooled sensitivity of 91% and specificity of 73%, indicating it is a valuable tool for targeting prostate cancer in challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of magnetic resonance imaging in the detection of prostate cancer in patients with previous negative biopsies and elevated prostate-specific antigen levels: a meta-analysis. Zhang, ZX., Yang, J., Zhang, CZ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11519108/

Performance of an ultra-fast deep-learning accelerated ... Diagnostic performance of the screening protocol was excellent with a sensitivity and specificity of 100%/100% and 89%/98% (cut-off ≥ PI-RADS 4) ...

2. eurradiolexp.springeropen.com eurradiolexp.springeropen.com/articles/10.1186/s41747-025-00615-9

Quantitative MRI Dixon signal drop and fat fraction for ... We found that a %drop of ≤ 19.8% and %fat of ≤ 18.3% effectively distinguished benign from malignant lesions with high accuracy.

3. jnm.snmjournals.org jnm.snmjournals.org/content/59/12/1913

The Effect of Including Bone in Dixon-Based Attenuation ... The objective of this study was to evaluate the effect of including bone in Dixon-based attenuation correction for 18F-fluciclovine PET/MRI of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12423374/

Quantitative MRI Dixon signal drop and fat fraction for ... Dixon metrics demonstrated superior diagnostic accuracy (86.6–87.2%), compared to conventional T1-weighted sequences (79.2%). Excellent inter- ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405631625001460

Leveraging dixon-based magnetic resonance imaging for ... All three DIXON-based MRI demonstrated high repeatability (intra-class correlation coefficients ≥0.97). •. Optimized parameters improved PDFF ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5457822/

Fat Suppressed Contrast-Enhanced T1-Weighted Dynamic ... In dynamic contrast-enhanced MRI of the prostate, the mDixon technique provided a better homogeneity of fat suppression without degrade of image quality.

7. nature.com nature.com/articles/s41598-017-04951-8

Normalized periprostatic fat MRI measurements can predict ... Periprostatic and pelvic fat have been shown to influence prostate cancer behaviour through the secretion of chemokines and growth factors, ...

8. jnm.snmjournals.org jnm.snmjournals.org/content/62/3/354

Urokinase-Type Plasminogen Activator Receptor (uPAR) PET ... uPAR PET/MRI could be a promising method for the noninvasive evaluation of PCa and might reduce the need for repeated biopsies (eg, in active surveillance).

9. mdpi.com mdpi.com/2072-6694/16/14/2531

Multiparametric Whole-Body MRI: A Game Changer in ... With promising potential for precise response assessment, WB-MRI emerges as a transformative tool in the management of metastatic prostate cancer. Abstract.

10. sciencedirect.com sciencedirect.com/science/article/pii/S0009926021002087

Whole-body MRI: a practical guide for imaging patients ... In prostate cancer, next-generation WB-MRI (including diffusion-weighted [DW] MRI and Dixon imaging) is useful for assessing the response of metastatic bone ...