Clinical trial · Interventional
Focal Prostate Imaging With CLE and OCT
In-vivo Focal Prostate Imaging With Confocal Laser Endomicroscopy and Optical Coherence Tomography
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The current limitations in prostate cancer diagnostics lead to over- and undertreatment for a significant fraction of patients. Confocal Laser Endomicroscopy (CLE) and Optical Coherence Tomography (OCT) are focal imaging modalities with potential for in-vivo prostate imaging. The investigators anticipate that integrating focal imaging with MRI/TRUS fusion will further improve prostate cancer detection and provides a real-time histopathological threedimensional representation of the tumor lesions. This is an investigator-initiated, prospective in-vivo safety and feasibility study with transperineal template mapping biopsies (TTMB) and two focal imaging methods, CLE and OCT, in prostate tissue.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Confocal Laser Endomicroscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Optical imaging
- description
- All consenting patients will undergo Confocal Laser Endomicroscopy or Optical Coherence Tomography imaging prior to biopsy or surgery.
- interventionNames
- Device: Confocal Laser Endomicroscopy
Primary outcomes (1)
- measure
- Visual image criteria for CLE and quantitative parameters (attenuation coefficient and residue) of OCT for the characterization of the prostate tissue
- timeFrame
- 2 years
- description
- * Describing visual characteristics on CLE imaging * Attenuation coefficient on OCT imaging calculated with our in-house build software * Residue of the OCT imaging calculated with our in-house build software
Secondary outcomes (2)
- measure
- Technical feasibility of CLE and OCT imaging in the prostate by a transperineal approach
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * age ≥ 18 years * signed informed consent * mpMRI data available Exclusion criteria * Patients with a known allergic reaction to fluorescein cannot participate in this study. * Documented acute prostatitis or urinary tract infections * No ability to stop anticoagulant or antiplatelet therapy * Medical history of a bleeding disorder or if available platelet Count \<140/uL, prothrombin time \>14.5 sec., partial thromboplastin time \>34 sec. * Major concurrent debilitating illness or ASA ≥4 * Biological or chemotherapy for PCa * Hormonal therapy within last six months * Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study * Is incapable of understanding the language in which the information for the patient is given
References
Publications (2)
- DERIVEDvan Riel LAMJG, Swaan A, Mannaerts CK, van Kollenburg RAA, Savci Heijink CD, de Reijke TM, de Bruin DM, Freund JE. Image-guided in-Vivo Needle-Based Confocal Laser Endomicroscopy in the Prostate: Safety and Feasibility Study in 2 Patients. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221093149. doi: 10.1177/15330338221093149. PMID 35790459
- DERIVEDSwaan A, Mannaerts CK, Scheltema MJ, Nieuwenhuijzen JA, Savci-Heijink CD, de la Rosette JJ, van Moorselaar RJA, van Leeuwen TG, de Reijke TM, de Bruin DM. Confocal Laser Endomicroscopy and Optical Coherence Tomography for the Diagnosis of Prostate Cancer: A Needle-Based, In Vivo Feasibility Study Protocol (IDEAL Phase 2A). JMIR Res Protoc. 2018 May 21;7(5):e132. doi: 10.2196/resprot.9813. PMID 29784633