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

Trial Summary

What is the purpose of this trial?

Multiparametric MRI (mpMRI) of the prostate is an important tool for diagnosis of clinically significant prostate cancer (csPCa) in men with an elevated serum prostate specific antigen, which can decrease the rate of unnecessary biopsies and reduce the incidence of over-diagnosis of non-csPCa. Furthermore, there is evidence that MRI is more accurate in detecting high-grade (Gleason grade group ≥3) versus low grade cancers (Gleason grade group \<2) and therefore may serve as a useful adjunct to prostate-specific antigen (PSA) testing, digital rectal examination, and prostatic biopsy to detect cancers that require definitive treatment as opposed to active surveillance. Many investigators, including our group, have shown the utility of preoperative mpMRI to assess the local extent of prostate cancer and for surgical planning.

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 data supports the effectiveness of the treatment using the Flexible AIR Coil for prostate cancer?

Research shows that using an endorectal coil in MRI scans can improve the detection and imaging quality of prostate cancer, helping doctors see the cancer more clearly. This suggests that similar coil technologies, like the Flexible AIR Coil, might also enhance imaging and aid in better diagnosis and treatment planning. ^{1 2 3 4 5}

Is the mpMRI with Flexible AIR Coil for Prostate Cancer safe for humans?

The research on endorectal coils, which are similar to the Flexible AIR Coil, shows that they have been used safely in humans for imaging the prostate. These coils provide high-resolution images and have been tested in patients with prostate conditions, indicating they are generally safe for use. ^{5 6 7 8 9}

How is the Flexible AIR Coil treatment for prostate cancer different from other treatments?

The Flexible AIR Coil treatment for prostate cancer is unique because it uses a non-endorectal coil for magnetic resonance imaging (MRI), which avoids the discomfort of traditional endorectal coils while still providing high-resolution images of the prostate. ^{3 5 6 10 11}

Research Team

Tharakeswara Bathala

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

I am a man aged 18 or older.

Exclusion Criteria

Cardiac pacemaker

My prostate cancer is considered low-risk.

I have claustrophobia or need anesthesia for procedures.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States 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. [2019]

3. Ireland 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. [2022]

4. United States 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. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Prostate: MR imaging with an endorectal surface coil. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Inflatable surface coil for MR imaging of the prostate. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of comfort and image quality with two endorectal coils in MRI of the prostate. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of prostate distortion by inflatable and rigid endorectal MRI coils in permanent prostate brachytherapy imaging. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

[Non-granulomatous prostatitis: MRI image with endorectal surface coil ("Endo-MRI")]. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

Education of prostate MR imaging: commentary. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Intracavitary birdcage resonator: applications to the human prostate. [2019]