Cutaneous MelanomaBMUMMNCT04702854
Evaluation of Ultrasound Biomicroscopy in the Local Staging of Cutaneous Melanoma
A study testing Ultrasound Biomicroscopy in people with Cutaneous Melanoma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Melanoma
- What is being tested?
- Ultrasound Biomicroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2024to 22 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical suspicion of cutaneous melanoma
- Age ≥ 18 years
- Social Security affiliation
- Approval of patient and signature of informed consent form
Who cannot join
- Counter-indication to the surgical resection of the cutaneous melanoma
- Vulnerable patient (Under-supervision patients or deprived of liberty patients)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Ultrasound Biomicroscopy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound BiomicroscopyDiagnostic test
Measure of cutaneous melanomas by ultrasound Biomicroscopy
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Measure of cutaneous melanomas by ultrasound biomicroscopy Receives: Diagnostic Test: Ultrasound Biomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Conventional High Frequency Ultrasound (18MHz) will be performed prior to Ultrasound Biomicroscopy analysis using an 18 MHz probe according to the usual technique used in High Frequency Ultrasound (freehand) and the thickness of the malignant melanoma will be expressed in µm. Standard gold is defined as at the main objective.
Measured: 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
High Frequency Ultrasound (33MHz) will be performed prior to Ultrasound Biomicroscopy analysis using an 33 MHz probe according to the usual technique used in High Frequency Ultrasound (freehand) and the thickness of the malignant melanoma will be expressed in µm. Standard gold is defined as at the main objective.
Measured: In the 14 days following the inclusion
Global echogenicity of the malignant melanoma in Ultrasound Biomicroscopy
Global echogenicity of the malignant melanoma in relation to the dermis: hypoechoic, isoechoic, hyperechoic
Measured: In the 14 days following the inclusion
Avascular areas of malignant melanoma using power Doppler in Ultrasound Biomicroscopy
Presence of Avascular areas of malignant melanoma using power Doppler in Ultrasound Biomicroscopy Data will be compared with the histological data
Measured: In the 14 days following the inclusion
Measurement of the thickness of the malignant melanoma with Ultrasound Biomicroscopy
Measurement of the thickness of malignant melanoma Ultrasound Biomicroscopy by 2 differents investigators to evaluate the intra and inter-observer matching.
Measured: In the 14 days following the inclusion
Measurement of the radiofrequency signal acquired during the Ultrasound Biomicroscopy examination of malignant melanoma
The radiofrequency signal acquired in Ultrasound Biomicroscopy will be analyzed on a platform dedicated to image processing, looking for radio frequency signal specifics of melanoma, compared to adjacent healthy skin.
Measured: In the 14 days following the inclusion
Structure of the malignant melanoma in Ultrasound Biomicroscopy
Homogeneous or heterogeneous structure of the malignant melanoma in Ultrasound Biomicroscopy
Measured: In the 14 days following the inclusion
Hyperechoic or anechogenic foci of the malignant melanoma in Ultrasound Biomicroscopy
Presence of hyperechoic or anechogenic foci in Ultrasound Biomicroscopy
Measured: In the 14 days following the inclusion
hyperechoic spans of the malignant melanomain Ultrasound Biomicroscopy
Presence of hyperechoic spans in Ultrasound Biomicroscopy
Measured: In the 14 days following the inclusion
Appearance of the contours of the melanoma
Appearance of the contours of the melanoma in Ultrasound Biomicroscopy : regular, irregular, or blurred
Measured: In the 14 days following the inclusion
Type of vascularization of malignant melanoma using power Doppler in Ultrasound Biomicroscopy
Type of vascularization of malignant melanoma using power Doppler in Ultrasound Biomicroscopy: homogeneous, heterogeneous Data will be compared with the histological data
Measured: In the 14 days following the inclusion
Intensity of vascularization relative to the adjacent normal dermis of malignant melanoma using power Doppler in Ultrasound Biomicroscopy
Intensity of vascularization relative to the adjacent normal dermis, with Doppler parameters fixed Data will be compared with the histological data
Measured: In the 14 days following the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start22 Feb 2024
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Why it stopped: recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MelanomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas AZULAY, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702854
- Sponsor's protocol ID
- 18-AOIP-04
- Acronym
- BMUMM
- Status last verified
- Feb 2024
- First submitted
- 2 Dec 2020
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasound Biomicroscopy in the Local Staging of Cutaneous Melanoma
- ClinicalTrials.gov ID
- NCT04702854
- Acronym / sponsor ID
- BMUMM / 18-AOIP-04
- Conditions
- Cutaneous Melanoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment challenges
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Diagnostic Test: Ultrasound BiomicroscopyMeasure of cutaneous melanomas by ultrasound biomicroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical suspicion of cutaneous melanoma
- Age ≥ 18 years
- Social Security affiliation
- Approval of patient and signature of informed consent form
Key exclusion criteria (2 listed)
- Counter-indication to the surgical resection of the cutaneous melanoma
- Vulnerable patient (Under-supervision patients or deprived of liberty patients)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound BiomicroscopyMeasure of cutaneous melanomas by ultrasound Biomicroscopy | Diagnostic test | Experimental |
Primary outcome
Measurement of the Breslow Index with Ultrasound Biomicroscopy
Time frame: In the 14 days following the inclusion
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.
12 secondary outcomes
Measurement of the thickness of the malignant melanoma with High Frequency Ultrasound (18MHz) and compare it to the result obtained by Ultrasound Biomicroscopy
Time frame: 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
Time frame: In the 14 days following the inclusion
Global echogenicity of the malignant melanoma in Ultrasound Biomicroscopy
Time frame: In the 14 days following the inclusion
Avascular areas of malignant melanoma using power Doppler in Ultrasound Biomicroscopy
Time frame: In the 14 days following the inclusion
Measurement of the thickness of the malignant melanoma with Ultrasound Biomicroscopy
Time frame: In the 14 days following the inclusion
Measurement of the radiofrequency signal acquired during the Ultrasound Biomicroscopy examination of malignant melanoma
Time frame: In the 14 days following the inclusion
Structure of the malignant melanoma in Ultrasound Biomicroscopy
Time frame: In the 14 days following the inclusion
Hyperechoic or anechogenic foci of the malignant melanoma in Ultrasound Biomicroscopy
Time frame: In the 14 days following the inclusion
hyperechoic spans of the malignant melanomain Ultrasound Biomicroscopy
Time frame: In the 14 days following the inclusion
Appearance of the contours of the melanoma
Time frame: In the 14 days following the inclusion
Type of vascularization of malignant melanoma using power Doppler in Ultrasound Biomicroscopy
Time frame: In the 14 days following the inclusion
Intensity of vascularization relative to the adjacent normal dermis of malignant melanoma using power Doppler in Ultrasound Biomicroscopy
Time frame: In the 14 days following the inclusion
Results and safety
The study was stopped early (reason given: recruitment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas AZULAY principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Biomicroscopy in people with Cutaneous Melanoma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment challenges). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the Breslow Index with Ultrasound Biomicroscopy (time frame: In the 14 days following the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.