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NCT03253458: FPI
Focal Prostate Imaging With CLE and OCT
NA trial testing Confocal Laser Endomicroscopy in Prostate Cancer in 14 participants. Status unknown.
31 December 2019
Quick facts
| Lead sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 14 |
| Start date | 11 May 2018 |
| Primary completion | 31 December 2019 |
| Estimated completion | 1 July 2020 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Confocal Laser Endomicroscopy
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →
Who can join
18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
The First In Vivo Needle-Based Optical Coherence Tomography in Human Prostate: A Safety and Feasibility Study.
Swaan A, Mannaerts CK, Muller BG, van Kollenburg RA, et al · · 2019 · cited 11× · PMID 31090088 · DOI 10.1002/lsm.23093 -
Confocal Laser Endomicroscopy and Optical Coherence Tomography for the Diagnosis of Prostate Cancer: A Needle-Based, In Vivo Feasibility Study Protocol (IDEAL Phase 2A).
Swaan A, Mannaerts CK, Scheltema MJ, Nieuwenhuijzen JA, et al · · 2018 · cited 8× · PMID 29784633 · DOI 10.2196/resprot.9813 -
Image-guided <i>in-Vivo</i> Needle-Based Confocal Laser Endomicroscopy in the Prostate: Safety and Feasibility Study in 2 Patients.
van Riel LAMJG, Swaan A, Mannaerts CK, van Kollenburg RAA, et al · · 2022 · cited 1× · PMID 35790459 · DOI 10.1177/15330338221093149
Verify or expand the search:
- PubMed search for NCT03253458
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03253458 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Last refreshed: 18 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03253458.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing