mpMRI with Flexible AIR Coil for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Low-risk adenocarcinoma, Other active malignancy, others
Stay on Your Current Meds
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Is 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.
56789How 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.
3561011Eligibility 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.
+2 more
Exclusion Criteria
Cardiac pacemaker
My prostate cancer is considered low-risk.
I have claustrophobia or need anesthesia for procedures.
+5 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
will have an mpMRI scan with an endorectal coil
Group II: Group 1Experimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas MD Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
References
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]The objective of this study was to determine the characteristics of prostate cancer foci missed on 3-T multiparametric MRI performed with an endorectal coil.
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]We investigated the performance of 3 Tesla multiparametric magnetic resonance imaging with and without an endorectal coil to detect prostate cancer with a whole mount histopathology reference.
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]To intraindividually compare image quality and diagnostic performance of multiparametric MRI (mpMRI) at 3T for the detection of prostate cancer (PCa) using a pelvic phased-array coil (PAC) and a combined endorectal and pelvic phased-array coil (ERC-PAC).
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]To evaluate the role of the combination of endorectal coil and external multicoil array magnetic resonance imaging (MRI) in the management of prostate cancer and predicting the surgical margin status in a single-surgeon practice.
Prostate: MR imaging with an endorectal surface coil. [2004]An endorectal surface coil has been developed to obtain high-resolution magnetic resonance images of the prostate. The probe consists of a surface coil mounted on the inner surface of a balloon. The balloon is concave to ensure tight seating against the prostate. The coil has been used in 15 patients with biopsy-proved prostatic carcinoma and in two healthy volunteers. The axial images were obtained with a 12-16-cm field of view and a 3-mm section thickness. Compared with images obtained with a body coil, the surface coil images better demonstrate prostatic anatomy and pathologic conditions.
Inflatable surface coil for MR imaging of the prostate. [2007]An inflatable surface coil for transrectal magnetic resonance imaging of the prostate was designed. The coil was tested during imaging of an insulated saline phantom and of the prostates of four patients. Phantom images were comparable to those obtained with commercial coils of similar size. High spatial resolution and excellent contrast were noted in coronal images of the prostates. Use of this coil could substantially improve studies of the prostate and cervix.
Comparison of comfort and image quality with two endorectal coils in MRI of the prostate. [2014]To prospectively evaluate comfort and image quality of prostate MRI using two different endorectal (ER) coils.
Comparison of prostate distortion by inflatable and rigid endorectal MRI coils in permanent prostate brachytherapy imaging. [2019]To study the deformation of the prostate by a rigid reusable endorectal coil and a balloon-type endorectal coil (BTC) during MRI of the prostate in brachytherapy imaging.
[Non-granulomatous prostatitis: MRI image with endorectal surface coil ("Endo-MRI")]. [2006]Inflammatory conditions of the prostate are often difficult to distinguish from early stages of prostate cancer with imaging techniques. The use of an endorectal surface coil in MRI of the prostate gland has been reported to provide superior resolution and better imaging of details than MRI with a body coil in the diagnosis of early prostate cancer. We report a 34-year-old patient with nonspecific non-granulomatous prostatitis in whom T2-weighted endorectal surface coil magnetic resonance imaging (ESCMRI) showed a region of markedly decreased signal intensity in the periphery of the gland. The low signal intensity of the lesion, its sharp demarcation from the normal part of the peripheral zone of the prostate and the marked bulge of the surface contour without capsular breach of the organ were interpreted as evidence of a bioptically proven benign inflammatory condition.
Education of prostate MR imaging: commentary. [2021]Multiparametric MRI (mpMRI) of the prostate has been firmly established as a tool in the diagnosis, management, and treatment of prostate cancer. The growth in this field over the past decade has led to increased acceptance and demand for multiparametric prostate MRI across the world. However, with the rising demand for prostate mpMRI, it will become increasingly necessary to train a generation of dedicated prostate imagers to yield a high-quality product.
Intracavitary birdcage resonator: applications to the human prostate. [2019]Twenty-five patients with prostatic cancer were prospectively examined with a prototype endorectal surface coil featuring a birdcage resonator circuit design. The purpose was to determine the safety of an intracavitary probe for magnetic resonance (MR) imaging of the pelvis that incorporates the "inside-out" characteristics of a volume coil design and allows high-resolution MR imaging of the prostate and potentially serves as an alternative to single-loop intracavitary surface coils. Clinically useful images supplementing images obtained with the body or external surface coils were obtained with the prototype probe. It was tolerated by all patients enrolled in the study, and none experienced side effects. The cylindrically symmetric sensitivity profile of the probe allowed identification of prostate tumors and pelvic lymph node and bone metastases. Volume-type coils may improve endopelvic MR imaging when used alone or in combination with external coil systems.