OCT and Invasion in Cutaneous Skin Lesions

Diagnosis Clinical Trial

Official title:

The Value of Optical Coherence Tomography in Discrimination Between the Presence and Absence of Invasion in Clinical Actinic Keratosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06014697
• Other study ID #: 2023-3735
• Status: Active, not recruiting
• Start date: March 1, 2023
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• patients who waived informed consent

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Optical Coherence Tomography
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)

Other:
• Clinical assessment
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)

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center+	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Sensitivity of OCT to detect invasion	Through study completion, an average of 6 months
Primary	Specificity	Specificity of OCT in determining the presence/absence of invasion	Through study completion, an average of 6 months
Secondary	Negative predictive value	Negative predictive value of OCT in determining the presence/absence of invasion	Through study completion, an average of 6 months
Secondary	Positive predictive value	Positive predictive value of OCT in determining the presence/absence of invasion	Through study completion, an average of 6 months
Secondary	Area under the curve	Area under the curve for OCT in determining the presence/absence of invasion	Through study completion, an average of 6 months
Secondary	Sensitivity of OCT features	Sensitivity for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.	Through study completion, an average of 6 months
Secondary	Difference OCT and clinical practice	Difference in diagnostic parameters (sensitivity, specificity and area under the curve) between OCT and clinical practice (clinical assessment).	Through study completion, an average of 6 months
Secondary	Specificity of OCT features	Specificity for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.	Through study completion, an average of 6 months
Secondary	Positive predictive value of OCT features	Positive predictive value for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.	Through study completion, an average of 6 months
Secondary	Negative predictive value of OCT features	Negative predictive value for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.	Through study completion, an average of 6 months
Secondary	Area under the curve for OCT features	Area under the curve for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.	Through study completion, an average of 6 months

External Links

•   VivoSight OCT Education Centre. VivoSight. 2022.