MRI Guided Prostate Biopsy

Trial Title: MRI Guided Prostate Biopsy

NCT ID: NCT06302595

Condition: Suspected Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
prostate cancer
prostate biopsy
MR-guided prostate biopsy
targeted biopsy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Device Feasibility

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: MRI-guided prostate biopsy using the needle holder frame.
Description: A needle holding frame will be used during a routine MRI-guided prostate biopsy procedure, where tissue samples are obtained from each suspected region found on MRI using an MRI-conditional core biopsy needle. In this routine procedure, tissue sampling is performed in an MRI gantry and intraprocedural MRI is used to localize the regions.
Arm group label: MRI-guided prostate biopsy

Summary: This study aims to assess the feasibility of magnetic resonance (MR) guided prostate biopsy using a needle holder frame. This frame is used to help position the needle used for the biopsy. The feasibility in this study is defined as whether the needle holder frame enables accurate tissue sampling from a suspicious region in the prostate found on an MR image. If it does, a biopsy can be carried out with the needle holder frame safely in a clinical routine. The study will be conducted during a routine MR-guided prostate biopsy procedure with an investigational needle holder frame instead of a conventional needle-guiding template.

Detailed description: The study will be conducted during a routine MR-guided prostate biopsy procedure. The following protocol follows the workflow of the routine procedure, except that the needle holder frame is used in place of a conventional needle-guiding template. The treating physicians have decided that an MR-guided prostate biopsy is necessary under the participant's current condition. If the participant chooses to participate in this research study, the procedure will be done in an MR scanner with an investigational needle holder frame. Before the MR-guided prostate biopsy, the participant already had a standard clinical prostate MRI, the images from which will be used during the procedure. The MR-guided prostate biopsy procedure may require monitored anesthesia or sedation. The participant will meet with the study physician prior to the biopsy procedure. The study physician will decide the type of monitored anesthesia or sedation to be used in discussion with the participant. When undergoing a study in the MRI system, the participant will lie motionless inside the gantry of the system. Occasionally, the machine will produce a loud banging noise, as if it were being pounded from the outside with a hammer. Earplugs are available to reduce this sound level. While the participant is in the magnet, under the anesthetic, the study physician will do the biopsy. To do this, the study physician will use a needle holder frame, which will show us where to put the needle by lining up the correct place outside on the skin or rectal wall. Like the routine procedure, the biopsy is done with a needle put through the skin under the participant's scrotum by the doctor. The location of the needle is confirmed by acquiring an MR image (confirmation image). Several biopsies are taken each time, from either side of the gland and from places where the MR images show shadows or abnormal areas. There can be a range of 6-15 locations to sample. Because the location of the needle is always confirmed on the confirmation image, like the routine procedure, the use of the needle holder frame will not compromise the sampling of MR-indicated abnormal areas. The participant will be in the study for about 1.5 hours, which is how long the biopsy procedure will take. After the procedure, the investigator will review the confirmation images to assess the accuracy of needle placement, though it will not change the health outcome (e.g., pathological findings).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Either an abnormal serum prostate-specific antigen (PSA) level (> 4ng/Ml) or a palpable nodule in the prostate on digital rectal examination or prostate MRI suspicious lesion.. - Diagnostic MRI of the prostate gland. - Age > 30 years - Signed informed consent. - No contra-indications to MRI, i.e. no cardiac pacemaker. - No recent or ongoing active ischemic heart disease. Exclusion Criteria: - Inability to give informed consent. - Contra-indications to MRI- cardiac pacemaker, inner ear implants, non-MR compatible intracranial aneurysm clips. - Recent or ongoing active ischemic heart disease such as recent or ongoing angina.

Gender: Male

Minimum age: 30 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Brigham and Women's Hospital

Address:
City: Boston
Zip: 02115
Country: United States

Status: Recruiting

Contact:
Last name: Kemal Tuncali, MD

Phone: 617-732-7631
Email: ktuncali@bwh.harvard.edu

Start date: August 24, 2023

Completion date: August 31, 2024

Lead sponsor:
Agency: Brigham and Women's Hospital
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Collaborator:
Agency: Physical Sciences Inc.
Agency class: Other

Source: Brigham and Women's Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06302595