mpMRI with Flexible AIR Coil for Prostate Cancer

Overseen By Tharakeswara Bathala, MBBS,MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Low-risk adenocarcinoma, Other active malignancy, others

Stay on Your Current Meds You can continue your current medications while participating

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

258 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a type of MRI scan, using a flexible coil, can help detect serious prostate cancer in men. The goal is to determine if this scan can better identify which cancers require treatment and which can be safely monitored over time. Two groups will be tested: one using a Flexible AIR Coil (a type of MRI coil) and the other using a standard coil. Men who have not yet received treatment for intermediate or high-risk prostate cancer (as confirmed by a biopsy) and are planning surgery soon might be suitable for this trial.

As an unphased study, this trial offers a unique opportunity to advance diagnostic methods for prostate cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these MRI coils are safe for prostate cancer diagnosis?

Research shows that both the Flexible AIR Coil and the endorectal coil have been safely used in prostate imaging. The Flexible AIR Coil is designed for specialized MRI scans that aid in diagnosing prostate cancer. Studies indicate that similar coil technologies have operated without major safety issues.

The endorectal coil also enhances image quality, facilitating the detection of smaller and less aggressive cancers. No major safety concerns have been reported for this coil.

Overall, both coils are well-tolerated, with studies noting no significant adverse events. This suggests they are safe for use in prostate imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of a flexible AIR coil for mpMRI scans in prostate cancer detection, which could offer several advantages over traditional methods. Unlike the standard endorectal coil, the flexible AIR coil is designed to be more comfortable for patients, potentially improving the overall experience during scanning. Additionally, the flexible AIR coil might provide enhanced image quality with greater flexibility, which could lead to more precise detection and characterization of prostate cancer. This trial could pave the way for more patient-friendly and accurate diagnostic tools in prostate cancer care.

What evidence suggests that this trial's MRI techniques could be effective for prostate cancer?

In this trial, participants will be divided into two groups to compare different coil types used in multiparametric MRI (mpMRI) for prostate cancer detection. Group 1 will undergo an mpMRI scan with a flexible AIR coil, while Group 2 will use an endorectal coil. A study of 429 patients found that using an endorectal coil in mpMRI did not significantly improve overall diagnostic results compared to non-endorectal coils. Other research has shown that endorectal coils can enhance image quality and help detect smaller and less aggressive prostate cancers. However, they can also cause more movement and image issues, potentially affecting results. The flexible AIR coil, a non-endorectal option, is under study to determine if it can detect prostate cancer as effectively as the standard endorectal coil without these problems. Initial findings suggest that both methods have their advantages, but the flexible AIR coil might offer a more comfortable experience with similar effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Tharakeswara Bathala

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Men over 18 with intermediate to high-risk prostate cancer that hasn't been treated yet. They must be eligible for a specific type of MRI scan and considering surgery within the next 6 months. Excluded are those with certain types of prostate cancer, prior treatments, or conditions like severe hemorrhoids, recent surgeries, other active cancers in the last two years, pacemakers, or claustrophobia.

Inclusion Criteria

I am planning to have surgery to remove my prostate as a cure, after having an mpMRI.

My prostate cancer is aggressive and hasn't been treated yet.

Patient has provided written informed consent for participation in this trial

Exclusion Criteria

Cardiac pacemaker

I have claustrophobia or need anesthesia for procedures.

My prostate cancer is considered low-risk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo mpMRI scans with either a flexible AIR coil or an endorectal coil

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

• Endorectal Coil
• Flexible AIR Coil

Trial Overview The study is testing how well two different MRI techniques using flexible AIR coils and endorectal coils can identify clinically significant prostate cancer. It aims to see if these methods can help avoid unnecessary biopsies by better detecting aggressive cancers needing treatment versus less serious ones that might only need monitoring.

How Is the Trial Designed?

Group I: Group 2 Experimental Treatment 1 Intervention

will have an mpMRI scan with an endorectal coil

Group II: Group 1 Experimental Treatment 1 Intervention

will have an mpMRI scan with a flexible AIR coil.

Flexible AIR Coil is already approved in European Union, United States for the following indications:

Approved in European Union as Flexible AIR Coil for:

• Diagnostic imaging for prostate cancer
• Assessment of local extent of prostate cancer
• Surgical planning

Approved in United States as Flexible AIR Coil for:

• Diagnostic imaging for prostate cancer
• Assessment of local extent of prostate cancer
• Surgical planning

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a study of 45 patients, multiparametric MRI (mpMRI) using a combined endorectal and pelvic phased-array coil (ERC-PAC) provided significantly better image quality for T2-weighted imaging compared to a pelvic phased-array coil (PAC).

Despite the improved image quality with the ERC-PAC, the diagnostic performance for detecting prostate cancer did not significantly differ between the two coil setups, and patients preferred the less invasive PAC, suggesting that the ERC may not be necessary for effective prostate cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

T2- and diffusion-weighted magnetic resonance imaging at 3T for the detection of prostate cancer with and without endorectal coil: An intraindividual comparison of image quality and diagnostic performance. Baur, AD., Daqqaq, T., Wagner, M., et al.[2022]

In a study of 429 patients undergoing 3 Tesla multiparametric MRI before prostatectomy, the use of an endorectal coil did not significantly improve overall prostate cancer detection rates compared to MRI without the coil, with detection rates of 50.5% and 48.2%, respectively.

However, the endorectal coil significantly enhanced the detection of posterior and peripheral prostate cancers, while it was less effective for anterior and transition zone lesions, indicating that the choice of imaging method may influence the detection of specific cancer locations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three Tesla Multiparametric Magnetic Resonance Imaging: Comparison of Performance with and without Endorectal Coil for Prostate Cancer Detection, PI-RADS™ version 2 Category and Staging with Whole Mount Histopathology Correlation. Mirak, SA., Shakeri, S., Bajgiran, AM., et al.[2019]

Endorectal surface coil MRI (ESCMRI) provides superior imaging resolution for diagnosing prostate conditions compared to traditional body coil MRI, which is crucial for distinguishing between inflammatory conditions and early prostate cancer.

In a case study of a 34-year-old patient, ESCMRI revealed a sharply defined low signal intensity area in the prostate, which was confirmed to be a benign inflammatory condition, demonstrating the technique's effectiveness in avoiding unnecessary cancer diagnoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Non-granulomatous prostatitis: MRI image with endorectal surface coil ("Endo-MRI")]. Szolar, DH., Ranner, G., Preidler, KW., et al.[2006]

In a study of 122 patients undergoing 3-T multiparametric MRI for prostate cancer, 53.3% of cancer foci detected by histopathology were missed on MRI, with most missed lesions being low-grade cancers (Gleason score of 6).

The MRI showed significantly higher sensitivity for detecting larger lesions (1 cm or more) and higher-grade cancers (Gleason score of 7 or greater), indicating that smaller and lower-grade lesions, especially those located in the apex of the prostate, are more likely to be overlooked.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of Detected and Missed Prostate Cancer Foci on 3-T Multiparametric MRI Using an Endorectal Coil Correlated With Whole-Mount Thin-Section Histopathology. Tan, N., Margolis, DJ., Lu, DY., et al.[2022]

The combination of endorectal coil and external multicoil array MRI demonstrated high specificity (99%) and accuracy (91%) in staging T3 prostate cancer, aiding in treatment decisions for 232 patients evaluated over a median follow-up of 4.5 years.

In patients who underwent radical prostatectomy, a single tumor length greater than 1.8 cm was associated with a higher rate of positive surgical margins (16%), highlighting the importance of tumor size in predicting surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of endorectal coil magnetic resonance imaging in treatment of patients with prostate cancer and in determining radical prostatectomy surgical margin status: report of a single surgeon's practice. Zhang, JQ., Loughlin, KR., Zou, KH., et al.[2018]

The newly designed inflatable surface coil for transrectal MRI of the prostate produced high-quality images comparable to commercial coils, indicating its potential effectiveness in clinical settings.

Testing on four patients showed that the coil provided high spatial resolution and excellent contrast in imaging, suggesting it could significantly enhance prostate and cervix studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inflatable surface coil for MR imaging of the prostate. Martin, JF., Hajek, P., Baker, L., et al.[2007]

The endorectal surface coil developed for MRI provides high-resolution images of the prostate, improving the visualization of both normal anatomy and pathological conditions.

In a study involving 15 patients with prostate cancer and 2 healthy volunteers, the surface coil images outperformed traditional body coil images, highlighting its potential for better diagnostic accuracy in prostate examinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate: MR imaging with an endorectal surface coil. Schnall, MD., Lenkinski, RE., Pollack, HM., et al.[2004]

Multiparametric MRI (mpMRI) is a crucial tool for diagnosing and managing prostate cancer, showing significant growth and acceptance in the medical field over the past decade.

As the demand for prostate mpMRI increases globally, there is a pressing need to train specialized imagers to ensure high-quality imaging results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education of prostate MR imaging: commentary. Merritt, BA., Behr, SC.[2021]

The prototype endorectal surface coil used in this study was well-tolerated by all 25 patients with prostatic cancer, with no reported side effects, indicating its safety for use in MR imaging.

This new imaging probe provided clinically useful high-resolution images of the prostate and surrounding areas, potentially improving the detection of prostate tumors and metastases compared to traditional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracavitary birdcage resonator: applications to the human prostate. Merchant, TE., Schwartz, LH., Ballon, D., et al.[2019]

In a study of 52 prostate cancer patients, the balloon-type endorectal coil (BTC) caused significantly more deformation of the prostate (3.9 mm) compared to the rigid endorectal coil (REC) (2.0 mm), indicating that the REC is a better option for minimizing distortion during MRI.

The study found that the anterior-to-posterior to left-to-right (AP/LR) ratio can effectively measure prostate distortion, with a lower ratio observed with the BTC (0.62) compared to no coil (0.76) or REC (0.73), suggesting that the REC maintains better prostate shape during imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of prostate distortion by inflatable and rigid endorectal MRI coils in permanent prostate brachytherapy imaging. Martin, GV., Kudchadker, RJ., Bruno, TL., et al.[2019]

Patients experienced significantly less discomfort with the colorectal endocoil (CEC) compared to the prostate endocoil (PEC), with average pain ratings of 2.7 for CEC versus 5.0 for PEC (P < 0.03).

The CEC provided superior image quality, being 5.8 times more likely to yield excellent ratings for identifying the neurovascular bundle and 3.5 times more highly rated overall, indicating it may enhance diagnostic accuracy in prostate MRI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of comfort and image quality with two endorectal coils in MRI of the prostate. Powell, DK., Kodsi, KL., Levin, G., et al.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9030903/

Prostate MRI: Is Endorectal Coil Necessary?—A Review - PMC Endorectal coils improved quantitative and qualitative image quality and diagnostic performance in the detection of smaller and less aggressive cancers in 3T ...

2. pubs.rsna.org pubs.rsna.org/doi/10.1148/ryai.230555

Impact of Scanner Manufacturer, Endorectal Coil Use, and ... Deep learning models helped predict aggressiveness of prostate cancer using only biparametric MRI, with no lesion annotations or lesion location ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8177947/

Preliminary results of endorectal surface coil magnetic ... ERC-MRI predicted correctly a T3 tumor in 10 of 12 cases and a T2 tumor in 4 of 7 cases. ERC-MRI was 74% accurate in differentiating T2 from T3 tumor. Three ...

4. clinicalradiologyonline.net clinicalradiologyonline.net/article/S0009-9260(19)30590-2/pdf

Head-to-head comparison of prostate MRI using an ... The primary outcome assessed in this meta-analysis was the diagnostic performance of prostate MRI using an ERC and prostate MRI using a BAC/PAC in staging T3a, ...

5. urotoday.com urotoday.com/library-resources/prostate-cancer-active-surveilance/111528-prostate-cancer-and-utilization-of-multi-parametric-mri.html

Prostate Cancer and Utilization of Multi-Parametric MRI Based on these data, a triage mpMRI would allow 25% of men to safely avoid a prostate biopsy, while at the same time reducing detection of ...

6. ajronline.org ajronline.org/doi/10.2214/AJR.18.20266

Safety and Image Quality of 1.5-T Endorectal Coil ... Multiparametric 1.5-T MRI examination of the prostate can be safely performed in selected patients with CIEDs under controlled conditions with applicable image ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4865450/

Development and evaluation of a multi-channel endorectal ... Numerically computed transmit/receive and safety performance of ERC-2L and ERC-ML are listed in Table 1, and SNR distributions are shown in Supplemental Figure ...

8. mdpi.com mdpi.com/2075-1729/12/4/569

Prostate MRI: Is Endorectal Coil Necessary?—A Review Endorectal coils improved quantitative and qualitative image quality and diagnostic performance in the detection of smaller and less aggressive cancers in 3T ...

9. auanet.org auanet.org/guidelines-and-quality/guidelines/other-clinical-guidance/mri-of-the-prostate-sop

Prostate Cancer Optimal scanning technique should utilize 3.0T surface coil; the need for an endorectal coil at 3.0T remains debated; an endorectal coil may be necessary for ...

10. sperlingprostatecenter.com sperlingprostatecenter.com/dont-use-endorectal-coil-mri/

New Research Updates Affirm Why I Don't Use an ... I want to share two recent studies that confirm the endorectal coil offers no advantage over external body coils.