Evaluation of Ultrasound Biomicroscopy in the Local Staging of Cutaneous Melanoma

NCT04702854 | Recruiting

• 1 other identifier: 18-AOIP-04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Cutaneous melanomas represent 4 to 11% of cutaneous cancers, but is responsible for 75% of the deaths reported for these pathologies. The incidence rate double every 10 years. Fourteen thousand cases and 1700 deaths were reported in France in 2015. The local staging of the cancer is represented by the Breslow index, which is measured on histological analysis, corresponding to the maximum depth of the cancer. Breslow index is a good pronostic value, and is used to choose for the best treatment for the patient. Having access to the Breslow index before the first resection of the tumor would allow dermatologists to make a complete resection with the best treatment, and the analysis of the sentinel lymph node, all during the same surgical time. Currently, patients need 2 surgeries : one before the Breslow index, and a second one after. The depth of cutaneous melanoma was already evaluated with High-Frequency Ultrasound (HF-US), but gave disappointing results, with Breslow index not being accurately measured. Only 50% of tumors less than 2mm depth were efficiently measured. Results were even worst for bigger tumors. Ultrasound biomicroscopy (UBM) is a new approach, depending on the use of ultra high frequency and large-band transducer. Nice's CHU acquired the only ultrasound device capable of applying such ultra high frequency ultrasound (UHF-US) to human tissues. The device is a VEVO MD (Vevo MD, Toronto, Canada) and equip the Ultrasound Department since June 2018. The images investigators can assess with this device have an axial resolution of 30µm, for a maximum emission frequency of 70MHz, which was not attainable until this day in human care. Furthermore, when compared to some of the mono-frequency devices investigators experimented before, this device allow investigators to attain a maximum depth of analysis up to 8mm. In consequence, this device seems to be able to realize an extremely precise analysis of the skin, and of the cutaneous melanomas, for a structural analysis, as well as a precise depth measurement, and should be evaluated in the measurement of the Breslow Index. The objective of the study is to analyze the interest of ultrasound biomicroscopy in the pre-therapeutic evaluation of the Breslow index of cutaneous melanoma, compared to histological findings. The study will include 60 patients with cutaneous melanomas, recently diagnosed in the Dermatology Department of the Nice University Hospital (Pr Bahadoran, Pr Passeron, Pr Lacour). Each patient will beneficiate from complete Ultrasound biomicroscopy analysis of the tumor The examination will be made blindly by 2 operator, both with experience in Ultra High frequency Ultrasound examinations (Dr Azulay, Dr Raffaelli). The maximum depth of the melanoma (Breslow index) will be recorded in µm. After surgical resection, the histologic analysis (Dr Long, Pr Hofman, Clinical and Experimental AnatomoPathologic laboratory, Nice's University Hospital) will measure the gold-standard Breslow Index. The comparison will analyze the capacity of Ultrasound biomicroscopy for a precise measurement of the Breslow Index, as well as the inter and intra-operator concordance. If the results of this study are positives and suggest a modification of the therapeutic strategy, a larger multicentric study would be launched in the near future.

Conditions

Cutaneous Melanoma

Outcome Measures

Primary Outcomes (1)

• Measurement of the Breslow Index with Ultrasound Biomicroscopy

  The measurement of the thickness of the malignant melanoma will be carried out in Ultrasound Biomicroscopy in two orthogonal planes using the maximum value obtainedThe measurement will be performed pre-operatively with the device (transducer) attached to an articulated arm from the anterior edge of the lesion to the interface between the posterior border of the lesion and the underlying dermis or hypodermis. The measurement will be expressed in mm. The histological measurement will be performed according to the usual techniques after fixation of the surgical specimen. It will also be expressed in µm.

  In the 14 days following the inclusion

Secondary Outcomes (12)

• Measurement of the thickness of the malignant melanoma with High Frequency Ultrasound (18MHz) and compare it to the result obtained by Ultrasound Biomicroscopy

  In the 14 days following the inclusion

• Measurement of the thickness of the malignant melanoma with High Frequency Ultrasound and compare it to the result obtained by Ultrasound Biomicroscopy

  In the 14 days following the inclusion

• Global echogenicity of the malignant melanoma in Ultrasound Biomicroscopy

  In the 14 days following the inclusion

• Avascular areas of malignant melanoma using power Doppler in Ultrasound Biomicroscopy

  In the 14 days following the inclusion

• Measurement of the thickness of the malignant melanoma with Ultrasound Biomicroscopy

  In the 14 days following the inclusion

Study Arms (1)

Experimental

EXPERIMENTAL

Measure of cutaneous melanomas by ultrasound biomicroscopy

Diagnostic Test: Ultrasound Biomicroscopy

Interventions

Ultrasound Biomicroscopy DIAGNOSTIC_TEST

Measure of cutaneous melanomas by ultrasound Biomicroscopy

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical suspicion of cutaneous melanoma
• Age ≥ 18 years
• Social Security affiliation
• Approval of patient and signature of informed consent form

You may not qualify if:

• Counter-indication to the surgical resection of the cutaneous melanoma
• Vulnerable patient (Under-supervision patients or deprived of liberty patients)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, France

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Microscopy, Acoustic

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Investigative Techniques

Study Officials

• Nicolas AZULAY

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas AZULAY

CONTACT

04 92 03 77 16; azulay.n@chu-nice.fr

Charles RAFFAELLI

CONTACT

raffaelli.c@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: January 11, 2021
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

FR (1)