Impact of Preoperative High-Frequency Ultrasound Cutaneous Lesion Extent Assessment on Excision Margin Positivity in Head and Neck Skin Cancer, and the Relationship Between Preoperative Assessment Methods, Inadequate Excision Margins, and Tumor Recurrence

Summary

Non-melanoma skin cancers (NMSC), particularly basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC), are the most common malignancies in Caucasians, with the majority of tumors located in the head and neck due to chronic ultraviolet exposure. Although BCC has very low metastatic potential, while cSCC carries a higher risk of nodal spread, both can cause significant local tissue destruction and functional and cosmetic impairment. Complete excision with histologically clear margins remains the standard treatment; however, incomplete or close excision margins are reported in a substantial proportion of cases and are associated with increased risk of local recurrence, need for additional treatment, and higher healthcare costs.

Preoperative dermoscopy improves delineation of lateral tumor borders but does not assess depth of invasion. High-frequency ultrasound (HFUS) is a rapid, non-invasive imaging modality that can visualize superficial skin structures and estimate tumor thickness. Previous studies have suggested good agreement between HFUS and histopathologic depth of invasion, but results are not fully consistent, and HFUS has not yet been incorporated into major guideline recommendations for preoperative assessment of NMSC. Further prospective data are needed to clarify whether HFUS can improve surgical planning and margin control.

This prospective study is designed to assess the impact of adding preoperative HFUS to standard dermoscopic evaluation in head and neck BCC and cSCC. The primary objectives are: (1) to compare the frequency of positive or inadequate (\<1 mm) histopathologic excision margins between lesions assessed with dermoscopy alone and those assessed with both dermoscopy and HFUS; and (2) to evaluate 5-year local recurrence rates in relation to preoperative assessment method, histopathologic margin status, and subsequent management of inadequate margins (observation, non-surgical treatment, or scar excision). Secondary and additional objectives include: assessing concordance between HFUS-measured and histopathologic depth of invasion; determining the frequency of residual tumor in scars excised after inadequate margins; evaluating recurrence rate according to the site of inadequate margins (lateral vs deep); and identifying patient-related, tumor-related, surgical, and histopathologic predictors of inadequate margins and recurrence. Approximately 400 lesions (BCC or cSCC of the head and neck) qualified for curative surgical excision will be included. Each lesion will constitute an independent study case. All lesions will undergo preoperative assessment, including clinical evaluation with detailed medical history and dermoscopy; in one cohort, lesions will additionally be evaluated with HFUS. HFUS will be performed with an 18-MHz linear probe, using superficial B-mode and color Doppler. Maximum tumor depth will be recorded from the epidermal surface (or granular layer) to the deepest hypoechoic point, with assessment of potential infiltration of deeper structures when visible. Surgical excision and postoperative care will follow standard clinical practice. Postoperative histopathologic assessment of FFPE tumor samples will record tumor histologic type and subtype, margin status, width, depth of invasion, differentiation, inflammation, elastosis, perineural or vascular invasion, and other routinely assessed diagnostic features. In the event of positive or inadequate excision margins, patients will be referred, after consultation with a dermatologist, for further management (observation, non-surgical treatment, or scar excision), depending on clinical indications and patient preferences. Participation in the study will not influence the primary surgical treatment or any decisions regarding subsequent management.

Patients will be followed for at least 5 years according to current clinical guidelines, with dermoscopic skin examination and documentation of local recurrence and its management. The study aims to determine whether incorporating HFUS into preoperative assessment can reduce the frequency of inadequate histologic margins and improve long-term local control in head and neck NMSC.

Conditions

• Basal Cell Carcinoma of Skin
• Cutaneous Squamous Cell Carcinoma (CSCC)
• Cutaneous Squamous Cell Carcinoma in Situ (CSCCis)
• Cutaneous Squamous Cell Carcinoma of the Head and Neck
• Basal Cell Carcinoma (BCC)
• Basal Cell Carcinoma of the Head and Neck
• Non-Melanoma Skin Cancer (NMSC)

Interventions

DIAGNOSTIC_TEST

High-Frequency Ultrasound

High-frequency ultrasound examination of the tumor will be performed using a GE LOGIQ S7 Expert system with an L8-18i-D linear probe (18 MHz). Imaging will include superficial-preset B-mode gray-scale assessment and color Doppler evaluation of lesion vascularity. Standard ultrasound gel will be applied; the probe will be positioned perpendicularly to the skin surface without pressure, avoiding direct contact with the tumor. Images and measurements will be obtained in at least two orthogonal planes. Maximum tumor depth will be recorded as the greatest value measured from the epidermal surface (or granular layer, when visible) to the deepest hypoechoic point of the lesion. When possible, infiltration of deeper structures (e.g., subcutaneous fat, salivary glands, muscle) will also be evaluated.

DIAGNOSTIC_TEST

Dermoscopy

All lesions will undergo standard preoperative dermoscopic evaluation performed by a consultant dermatologist, including assessment of tumor extent and marking of dermoscopically visible tumor borders.

Sponsors & Collaborators

• Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji

  lead OTHER_GOV

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-23

Primary Completion

2033-11-30

Completion

2033-11-30

Countries

• Poland

Study Locations