Real-time lesion targeting during MR-guided prostate biopsy using an iPad: a pilot study

Real-time lesion targeting during MR-guided prostate biopsy using an iPad: a pilot study - Real-time lesion targeting during MR-guided prostate biopsy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42502

Enrollment

Registered

2015-11-05

Start date

2016-06-27

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

malignant prostate tissue prostate cancer

Interventions

All subjects will undergo MR-guided prostate biopsy with real-time lesion targeting

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 21 years of age or more - PSA >4.0 ng/mL and/or positive digital rectal examination - Single suspicious lesion (PIRADS 4 or 5) on diagnostic MR imaging examination - Signed MRI screening form (to search for metal device/foreign bodies/claustrophobia) - Signed IRB-approved informed consent form

Exclusion criteria

Exclusion criteria: - Patients unable to undergo MR imaging, including those with contra-indications - Contra-indications to MR-guided prostate biopsy - Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the MR imaging quality - Multiple suspicious lesions on diagnostic MR imaging examination - Impossibility to obtain a valid informed consent

Design outcomes

Primary

Measure	Time frame
To establish the clinical feasibility in patients of real-time lesion targeting during MR-guided prostate biopsy using an iPad.	—

Secondary

Measure	Time frame
To evaluate the time to first biopsy and total procedure time of MR-guided prostate biopsy with and without real-time lesion targeting.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)