Last reviewed · How we verify
NCT06014697
OCT and Invasion in Cutaneous Skin Lesions
trial testing Optical Coherence Tomography in Cutaneous Squamous Cell Carcinoma in 71 participants. Completed in 1 August 2024.
1 June 2024
Quick facts
| Lead sponsor | Maastricht University Medical Center |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 71 |
| Start date | 1 March 2023 |
| Primary completion | 1 June 2024 |
| Estimated completion | 1 August 2024 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Optical Coherence Tomography
- Clinical assessment — full drug profile →
Conditions studied
- Cutaneous Squamous Cell Carcinoma — all drugs for Cutaneous Squamous Cell Carcinoma →
- Bowen's Disease — all drugs for Bowen's Disease →
- Actinic Keratoses — all drugs for Actinic Keratoses →
- Keratosis, Actinic — all drugs for Keratosis, Actinic →
Sponsor
Maastricht University Medical Center
Who can join
Eligibility, any sex, with Cutaneous Squamous Cell Carcinoma or Bowen's Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The increasing incidence of actinic keratosis (AK), morbus Bowen (MB) and cutaneous squamous cell carcinoma (cSCC), the patients with often multiple lesions and the disadvantages of invasive diagnostics show the need for an accurate non-invasive diagnostic tool for the determination of invasive growth in AK and MB. Optical coherence tomography (OCT) is a non-invasive scanner creating cross-sectional images of the skin, to a depth of 1-1,5 mm based on light waves. Until now, OCT has been proposed as non-invasive diagnostic tool for basal cell carcinomas. Although the diagnostic value of OCT for detection and sub-typing of basal cell carcinomas has already been demonstrated, it is unclear whether OCT can discriminate between invasive and non-invasive lesions (AK, MB and cSCCs). There are some studies that describe OCT characteristics of AK, MB and cSCCs, however, these characteristics have a lot of overlap (8-13). To date there are no clearly distinctive OCT features to distinguish between AK, MB and cSCCs. This study aims to investigate the value of OCT in discriminating between the presence and absence of invasion in lesions with clinical suspicion for invasion. Two experienced OCT-assessors will evaluate the OCT scans independently. The OCT assessors are blinded to the histological diagnosis of the lesions (invasive or non-invasive), which is used as golden standard. A 5-point Likert scale is used for OCT assessment. 1. Definitely not invasive 2. Probably not invasive 3. Unknown, probably invasive/probably not invasive 4. Probably invasive 5. Definitely invasive In addition to completing the Likert-scale, assessors are asked to describe the presence/absence of predefined OCT characteristics (a.o. hyperkeratosis and the presence of the dermo-epidermal junction) In case of disagreement between the independent assessors, the OCT scan will be re-assessed in a consensus meeting.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06014697
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Optical Coherence Tomography
Trials testing the same drug.
- NCT06906562 — A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metasta · Phase 2 · recruiting
- NCT07060196 — The Impact of Artificial Lighting on the Visual Capacity of Patients With Age-Related Macular Degeneration · not yet recruiting
- NCT07350304 — Comparison of Two OCT Device RNFL and GCIPL Measurements in Mild, Moderate, and Severe Glaucoma · completed
- NCT06419114 — Exploration of Optical Coherence Tomography-Guided Transbronchial Biopsy in Peripheral Pulmonary Lesions · recruiting
- NCT05859334 — Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment · Phase 2 · recruiting
Other recruiting trials for Cutaneous Squamous Cell Carcinoma
Currently open trials in the same condition.
- NCT07288073 — TIL Therapy in cSCC and MCC · Phase 2 · recruiting
- NCT07402616 — Ex Vivo Cutaneous SCC · NA · recruiting
- NCT06875609 — ctDNA in Cutaneous Squamous Cell Carcinoma · recruiting
- NCT06567314 — Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma · Phase 2 · recruiting
- NCT06659146 — Thermotherapy in Addition to SOC Palliative Radiotherapy · NA · recruiting
Other Maastricht University Medical Center trials
Trials by the same sponsor.
- NCT04603261 — Time to Excretion of Contrast, a Maastricht Prospective Observational Study · withdrawn
- NCT04598516 — Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30 · withdrawn
- NCT04597892 — Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast · withdrawn
- NCT07287358 — Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II · NA · not yet recruiting
- NCT07501780 — Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice · not yet recruiting
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 NCT06014697 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Maastricht University Medical Center
- Last refreshed: 4 April 2025
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/NCT06014697.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing