OCT and Invasion in Cutaneous Skin Lesions

NCT06014697 | Completed

• 1 other identifier: 2023-3735
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Definitely not invasive
2. 2.Probably not invasive
3. 3.Unknown, probably invasive/probably not invasive
4. 4.Probably invasive
5. 5.Definitely invasive

Conditions

Cutaneous Squamous Cell Carcinoma; Bowen's Disease; Actinic Keratoses; Keratosis, Actinic; Diagnosis

Keywords

Optical coherence tomography; Invasion; Diagnostic device; Non-invasive

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  Sensitivity of OCT to detect invasion

  Through study completion, an average of 6 months

• Specificity

  Specificity of OCT in determining the presence/absence of invasion

  Through study completion, an average of 6 months

Secondary Outcomes (9)

• Negative predictive value

  Through study completion, an average of 6 months

• Positive predictive value

  Through study completion, an average of 6 months

• Area under the curve

  Through study completion, an average of 6 months

• Sensitivity of OCT features

  Through study completion, an average of 6 months

• Difference OCT and clinical practice

  Through study completion, an average of 6 months

Study Arms (2)

Non-invasive lesion

Lesion with histological confirmation of a actinic keratosis or Bowens disease (non-invasive lesions).

Diagnostic Test: Optical Coherence Tomography; Other: Clinical assessment

Invasive lesion

Lesion with histological confirmation of a squamous cell carcinoma (invasive lesions).

Diagnostic Test: Optical Coherence Tomography; Other: Clinical assessment

Interventions

Optical Coherence Tomography DIAGNOSTIC_TEST

Assessment of the lesion with a non-invasive OCT scan according to a confidence scale (5-point Likert scale: 1 Definitely not invasive, 2 Probably not invasive, 3 Unknown invasive or non-invasive, 4 Probably invasive, 5 Definitely invasive)

Also known as: OCT

Invasive lesion; Non-invasive lesion

Clinical assessment OTHER

Clinical assessment of the lesion by a dermatologist according to a confidence scale (5-point Likert scale: 1 Definitely not invasive, 2 Probably not invasive, 3 Unknown invasive or non-invasive, 4 Probably invasive, 5 Definitely invasive)

Invasive lesion; Non-invasive lesion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with a histologically confirmed actinic keratosis, bowens disease or cutaneous squamous cell carcinoma, with a clinical differential diagnosis of actinic keratosis and/or bowens disease and cutaneous squamous cell carcinoma, included in a previous study. All patients retrospectively had a OCT scan.

You may qualify if:

• Patients who are included in a previous study on OCT, with written informed consent to use their data regarding OCT.
• Patients who retrospectively had an OCT scan for their skin lesion
• With a histological confirmed actinic keratosis, bowens disease or cutaneous squamous cell carcinoma of the skin
• with a differential diagnosis of a invasive lesion (cutaneous squamous cell carcinoma) and a non-invasive lesion (bowens disease or actinic keratosis).

You may not qualify if:

• patients who waived informed consent

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Netherlands

Location

Related Publications (11)

• Stratigos AJ, Garbe C, Dessinioti C, Lebbe C, Bataille V, Bastholt L, Dreno B, Fargnoli MC, Forsea AM, Frenard C, Harwood CAlpha, Hauschild A, Hoeller C, Kandolf-Sekulovic L, Kaufmann R, Kelleners-Smeets NW, Malvehy J, Del Marmol V, Middleton MR, Moreno-Ramirez D, Pellecani G, Peris K, Saiag P, van den Beuken-van Everdingen MHJ, Vieira R, Zalaudek I, Eggermont AMM, Grob JJ; European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC). European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 1. epidemiology, diagnostics and prevention. Eur J Cancer. 2020 Mar;128:60-82. doi: 10.1016/j.ejca.2020.01.007. Epub 2020 Feb 26.

  PMID: 32113941 BACKGROUND

• Hollestein LM, de Vries E, Nijsten T. Trends of cutaneous squamous cell carcinoma in the Netherlands: increased incidence rates, but stable relative survival and mortality 1989-2008. Eur J Cancer. 2012 Sep;48(13):2046-53. doi: 10.1016/j.ejca.2012.01.003. Epub 2012 Feb 16.

  PMID: 22342554 BACKGROUND

• Lomas A, Leonardi-Bee J, Bath-Hextall F. A systematic review of worldwide incidence of nonmelanoma skin cancer. Br J Dermatol. 2012 May;166(5):1069-80. doi: 10.1111/j.1365-2133.2012.10830.x.

  PMID: 22251204 BACKGROUND

• Sinx KAE, van Loo E, Tonk EHJ, Kelleners-Smeets NWJ, Winnepenninckx VJL, Nelemans PJ, Mosterd K. Optical Coherence Tomography for Noninvasive Diagnosis and Subtyping of Basal Cell Carcinoma: A Prospective Cohort Study. J Invest Dermatol. 2020 Oct;140(10):1962-1967. doi: 10.1016/j.jid.2020.01.034. Epub 2020 Mar 6.

  PMID: 32147505 BACKGROUND

• Moy RL. Clinical presentation of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):8-10. doi: 10.1067/mjd.2000.103343.

  PMID: 10607350 BACKGROUND

• Ahmady S, Jansen MHE, Nelemans PJ, Kessels JPHM, Arits AHMM, de Rooij MJM, Essers BAB, Quaedvlieg PJF, Kelleners-Smeets NWJ, Mosterd K. Risk of Invasive Cutaneous Squamous Cell Carcinoma After Different Treatments for Actinic Keratosis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2022 Jun 1;158(6):634-640. doi: 10.1001/jamadermatol.2022.1034.

  PMID: 35475852 BACKGROUND

• Levine A, Wang K, Markowitz O. Optical Coherence Tomography in the Diagnosis of Skin Cancer. Dermatol Clin. 2017 Oct;35(4):465-488. doi: 10.1016/j.det.2017.06.008. Epub 2017 Aug 9.

  PMID: 28886803 BACKGROUND

• Sattler E, Kastle R, Welzel J. Optical coherence tomography in dermatology. J Biomed Opt. 2013 Jun;18(6):061224. doi: 10.1117/1.JBO.18.6.061224.

  PMID: 23314617 BACKGROUND

• Boone MA, Marneffe A, Suppa M, Miyamoto M, Alarcon I, Hofmann-Wellenhof R, Malvehy J, Pellacani G, Del Marmol V. High-definition optical coherence tomography algorithm for the discrimination of actinic keratosis from normal skin and from squamous cell carcinoma. J Eur Acad Dermatol Venereol. 2015 Aug;29(8):1606-15. doi: 10.1111/jdv.12954. Epub 2015 Feb 5.

  PMID: 25656269 BACKGROUND

• Marneffe A, Suppa M, Miyamoto M, Del Marmol V, Boone M. Validation of a diagnostic algorithm for the discrimination of actinic keratosis from normal skin and squamous cell carcinoma by means of high-definition optical coherence tomography. Exp Dermatol. 2016 Sep;25(9):684-7. doi: 10.1111/exd.13036.

  PMID: 27095632 BACKGROUND

• Friis KBE, Themstrup L, Jemec GBE. Optical coherence tomography in the diagnosis of actinic keratosis-A systematic review. Photodiagnosis Photodyn Ther. 2017 Jun;18:98-104. doi: 10.1016/j.pdpdt.2017.02.003. Epub 2017 Feb 7.

  PMID: 28188920 BACKGROUND

Related Links

• VivoSight OCT Education Centre. VivoSight. 2022.

MeSH Terms

Conditions

Bowen's Disease; Keratosis, Actinic; Disease

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Precancerous Conditions; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• K Mosterd, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 28, 2023
• Study Start: March 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

NL (1)