In-vivo focal prostate imaging with confocal laser endomicroscopy and optical coherence tomography

In-vivo focal prostate imaging with confocal laser endomicroscopy and optical coherence tomography - FPI (focal prostate imaging)

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47550

Enrollment

Registered

2019-10-25

Start date

2018-05-11

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

carcinoma of the prostate prostate cancer

Interventions

Transperineal SFR and CLE measurements will be performed directly prior to the surgery procedure or prior to the TTMB. In case of surgery, intraprostatic plastic IV cannulas will be placed for histo

cancer

endomicroscopy

prostate

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: For procedure 1: planned for TTMB For procedure 2: Localized prostate cancer visible on MRI

Exclusion criteria

Exclusion criteria: Patients with a known allergic reaction to fluorescein

Design outcomes

Primary

Measure	Time frame
Procedure 1 primary parameters/endpoints: - Technical feasibility of CLE and OCT in the prostate by transperineal approach Procedure 2 primary parameters/endpoints: - In-vivo images made with CLE and OCT of the different tissues in the prostate, verified by histopathology	—

Secondary

Measure	Time frame
Procedure 1 secondary parameters/endpoints: - List of procedure-related adverse events of needle based OCT and CLE Procedure 2 secondary parameters/endpoints: - Technical feasibility of CLE and OCT in the prostate by transperineal approach - List of procedure-related adverse events of needle based OCT and CLE - Visual descriptive image criteria for CLE and OCT images of the different prostate tissues	—

Measure

Time frame

Procedure 1 secondary parameters/endpoints: - List of procedure-related adverse events of needle based OCT and CLE Procedure 2 secondary parameters/endpoints: - Technical feasibility of CLE and OCT in the prostate by transperineal approach - List of procedure-related adverse events of needle based OCT and CLE - Visual descriptive image criteria for CLE and OCT images of the different prostate tissues

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)