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NCT04229277
Fast Track Diagnosis of Skin Cancer by Advanced Imaging
NA trial testing optical coherence tomography in Malignant Melanoma in 41 participants. Completed in 1 June 2021.
22 March 2021
Quick facts
| Lead sponsor | University Hospital Bispebjerg and Frederiksberg |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 41 |
| Start date | 9 September 2019 |
| Primary completion | 22 March 2021 |
| Estimated completion | 1 June 2021 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- optical coherence tomography
Conditions studied
- Malignant Melanoma — all drugs for Malignant Melanoma →
- Nevus, Pigmented — all drugs for Nevus, Pigmented →
- Basal Cell Carcinoma — all drugs for Basal Cell Carcinoma →
- Seborrheic Keratosis — all drugs for Seborrheic Keratosis →
Sponsor
University Hospital Bispebjerg and Frederiksberg
Who can join
18 and older, any sex, with Malignant Melanoma or Nevus, Pigmented. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Aim of study: To collect data for a new image-guided diagnostic algoritm, enabling the investigators to differentiate more precisely between benign and malignant pigmented tumours at the bedside. This study will include 60 patients with four different pigmented tumours: seborrheic keratosis (n=15), dermal nevi (n=15), pigmented basal cell carcinomas (n=15), and malignant melanomas (n=15), these four types of tumours are depicted in Fig.1, and all lesions will be scanned by four imaging technologies, recruiting patients from Sept 2019 to May 2020. In vivo reflectance confocal microscopy (CM) will be used to diagnose pigmented tumours at a cellular level and provide micromorphological information5;6. Flourescent CM will be applied to enhance contrast in surrounding tissue/tumours. Optical coherence tomography (OCT), doppler high-frequency ultrasound (HIFU) and photoacustic imaging (also termed MSOT, multispectral optoacustic tomography) will be used to measure tumour thickness, to delineate tumours and analyze blood flow in blood vessels. Potential diagnostic features from each lesion type will be tested. Diagnostic accuracy will be statistically evaluated by comparison to gold standard histopathology
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Differentiation Between Benign and Malignant Pigmented Skin Tumours Using Bedside Diagnostic Imaging Technologies: A Pilot Study.
Von Knorring T, Israelsen NM, Ung V, Formann JL, et al · · 2022 · cited 9× · PMID 34806755 · DOI 10.2340/actadv.v101.571
Verify or expand the search:
- PubMed search for NCT04229277
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Malignant Melanoma
Currently open trials in the same condition.
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- NCT06974734 — A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies · Phase 1 · active not recruiting
- NCT06980740 — Video-Tumorboard PLUS · recruiting
- NCT06560905 — Preoperative Planning With PSMA-PET in Melanoma Surgery Trial · Phase 2 · recruiting
Other University Hospital Bispebjerg and Frederiksberg trials
Trials by the same sponsor.
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- NCT06532825 — Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure · recruiting
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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 NCT04229277 (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 University Hospital Bispebjerg and Frederiksberg
- Last refreshed: 20 June 2024
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/NCT04229277.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing