Biopsy results of the focal lesion detect by the artificial intelligence program for prostate MRI

Prospective, multi-center, single arm, investigator initiated trials exploratory study to assess the safety•efficacy of computer aided diagnosis software for prostate MRI

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006947

Enrollment

208

Registered

2022-01-20

Start date

2022-12-13

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : They are patients who have already found abnormalities in prostate magnetic resonance imaging and have decided to undergo prostate biopsy. Check for any abnormalities found in the pr

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Adults over 19 years old. 2) Patients undergoing prostate MRI due to clinically suspected prostate cancer during the period after IRB approval to December 31, 2023. 3) A patient who performs prostate MRI in the institutions 4) Patients who are determined to perform biopsy due to abnormalities detected in the MRI by radiologists or patients who are strongly suspected of prostate cancer although prostate MRI showed no abnormalities.

Exclusion criteria

Exclusion criteria: 1) 1.5-T MRI: image quality is low 2) MRI performed in patients already diagnosed with prostate cancer. 3) More than 120 days between MRI and prostate biopsy. 4) Patients who cannot understand the contents of the study due to cognitive impairment

Design outcomes

Primary

Measure	Time frame
Sensitivity of the AI software;Specificity of the AI software	—

Secondary

Measure	Time frame
Safety of the AI software	—

Countries

Korea, Republic of

Contacts

Public ContactMoon Hyung Choi

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

choimh1205@gmail.com+82-2-2030-3013

Outcome results