Informations générales (source: ClinicalTrials.gov)
Evaluation of Ultrasound Biomicroscopy in the Local Staging of Cutaneous Melanoma (BMUMM)
Interventional
N/A
Centre Hospitalier Universitaire de Nice (Voir sur ClinicalTrials)
mars 2024
mars 2025
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Nice - Nice - France | Nicolas AZULAY | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Clinical suspicion of cutaneous melanoma
- Age ≥ 18 years
- Social Security affiliation
- Approval of patient and signature of informed consent form
- Clinical suspicion of cutaneous melanoma
- Age ≥ 18 years
- Social Security affiliation
- Approval of patient and signature of informed consent form
- Counter-indication to the surgical resection of the cutaneous melanoma
- Vulnerable patient (Under-supervision patients or deprived of liberty patients)