Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigational protocol describes a small case series designed to compare three imaging modalities for use in visualizing prostate cancer.
The three modalities to be tested are: transrectal micro-ultrasound , and conventional resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI (mpMRI).
These modalities will be used for guiding systematic (standard, random, extended sextant) plus image-guided targeted prostate biopsies among men with known cancer and an indication for prostate biopsy.
In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the radiology report used for targeting.
This trial will enroll nine men with an indication for a prostate biopsy.
The primary objective of the study is to provide guidance to clinicians who will be using the ExactVu system on the appearance of suspicious foci, and the difference between the appearance of these foci in LR-TRUS, mpMRI and transrectal micro-ultrasound images.
The study is being conducted based on the hypothesis that a series of same-subject comparisons will clearly demonstrate the differences in appearance between the modalities.
Procedures in the study are:
The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities.
Secondary endpoints are the pathological result of each biopsy sample (Gleason Score and percentage of cancer in sample), and risk score identified on imaging. Both of these values are per-sample, with 12 systematic samples per subject plus any additional targeted samples warranted by standard of care.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micro-ultrasound | Experimental | Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound guided prostate exam using SOC ultrasound system | Device |
| ||
| mpMRI guided prostate examination using PI-RADS v2 |
| Measure | Description | Time Frame |
|---|---|---|
| Keyword Description of Each Biopsy Sample | The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound. | For each patient, keywords will be assigned within one week following the patient's procedure. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded from being included in the investigation if any of the following is true:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology of Virginia | Virginia Beach | Virginia | 23452 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Micro-ultrasound | Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:
Ultrasound guided prostate exam using SOC ultrasound system mpMRI guided prostate examination using PI-RADS v2: mpMRI guided prostate examination using standard of care MRI system High-resolution micro-ultrasound guided prostate biopsy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Micro-ultrasound | Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:
Ultrasound guided prostate exam using SOC ultrasound system mpMRI guided prostate examination using PI-RADS v2: mpMRI guided prostate examination using standard of care MRI system High-resolution micro-ultrasound guided prostate biopsy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Keyword Description of Each Biopsy Sample | The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound. | Posted | Number | percentage significant cancers detected | For each patient, keywords will be assigned within one week following the patient's procedure. |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Micro-ultrasound | Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:
Ultrasound guided prostate exam using SOC ultrasound system mpMRI guided prostate examination using PI-RADS v2: mpMRI guided prostate examination using standard of care MRI system High-resolution micro-ultrasound guided prostate biopsy |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Clinical Research | Exact Imaging | 905-415-0030 | 204 | bwodlinger@exactimaging.com |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
mpMRI guided prostate examination using standard of care MRI system |
|
| High-resolution micro-ultrasound guided prostate biopsy | Device |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |