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Optical Coherence Microscopy in Dermato-oncology (GALAXY)

Primary Purpose

Skin Cancer

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

OCTAV Patient

OCTAV Control group

About this trial

This is an interventional diagnostic trial for Skin Cancer focused on measuring Optical biopsy, Skin cancer, Diagnostic performance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

FOR PATIENT

Inclusion Criteria:

Patient with a cutaneous lesion suspicious for melanoma, basal cell carcinoma, squamous cell carcinoma, requiring a surgical excision
Consent form signed
Major patient

Exclusion Criteria:

Allergy or intolerance to immersion oil (used for microscopy)
If female, pregnant or breast-feeding
Patient unable to stand still for 60 seconds
Skin lesions located near patient eyes (<3 cm)

FOR CONTROL GROUP

Inclusion Criteria:

Aged between 18 to 40 years
Consent form signed
Patient of the dermatology department with non-pathological forearm skin

Exclusion Criteria:

Allergy or intolerance to immersion oil (used for microscopy)
If female, pregnant or breast-feeding
Patient unable to stand still for 60 seconds

Sites / Locations

Chu de Saint Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

OCTAV Patient

OCTAV Control group

Arm Description

The patients who will have a biopsy of skin suspected to be a melanoma, basal cell carcinoma or squamous cell carcinoma will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)

Control group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)

Outcomes

Primary Outcome Measures

Sensitivity

Sensitivity measures the proportion of positive skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)

Specificity

Specificity measures the proportion of negative skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)

Secondary Outcome Measures

Measure of the thickness of the different skin layers (mm)

Only for the non skin cancer group. Theses measures will identify the different skin layers (Epidermis, Dermis, Subcutaneous tissue, Cross-section)

Full Information

NCT ID

NCT03079232

First Posted

March 16, 2016

Last Updated

November 2, 2018

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

DAMAE Médical

1. Study Identification

Unique Protocol Identification Number

NCT03079232

Brief Title

Optical Coherence Microscopy in Dermato-oncology

Acronym

GALAXY

Official Title

In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

March 28, 2017 (Actual)

Primary Completion Date

August 1, 2018 (Actual)

Study Completion Date

August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

DAMAE Médical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

OCTAV is a medical device class I, not CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).

Detailed Description

At the coming of the patient in Dermatology for resection / biopsy of the tumor (usual practice), for the study, an image of the tumor will be performed with the OCTAV device (about 5 minutes) for the study. Then, according to usual practice, resection / biopsy will be performed. This study aims to validate the clinical relevance of this device to characterize the 3 main skin cancers and to obtain the necessary data for the implementation of future clinical trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin Cancer

Keywords

Optical biopsy, Skin cancer, Diagnostic performance

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

One group of patients One group of non skin cancer patients

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OCTAV Patient

Arm Type

Experimental

Arm Description

The patients who will have a biopsy of skin suspected to be a melanoma, basal cell carcinoma or squamous cell carcinoma will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)

Arm Title

OCTAV Control group

Arm Type

Experimental

Arm Description

Control group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)

Intervention Type

Device

Intervention Name(s)

OCTAV Patient

Other Intervention Name(s)

OCTAV, DAMAE Medical, Paris, France

Intervention Description

In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.

Intervention Type

Device

Intervention Name(s)

OCTAV Control group

Other Intervention Name(s)

OCTAV, DAMAE Medical, Paris, France

Intervention Description

In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.

Primary Outcome Measure Information:

Title

Sensitivity

Description

Sensitivity measures the proportion of positive skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)

Time Frame

Day 1

Title

Specificity

Description

Specificity measures the proportion of negative skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

Measure of the thickness of the different skin layers (mm)

Description

Only for the non skin cancer group. Theses measures will identify the different skin layers (Epidermis, Dermis, Subcutaneous tissue, Cross-section)

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

FOR PATIENT Inclusion Criteria: Patient with a cutaneous lesion suspicious for melanoma, basal cell carcinoma, squamous cell carcinoma, requiring a surgical excision Consent form signed Major patient Exclusion Criteria: Allergy or intolerance to immersion oil (used for microscopy) If female, pregnant or breast-feeding Patient unable to stand still for 60 seconds Skin lesions located near patient eyes (<3 cm) FOR CONTROL GROUP Inclusion Criteria: Aged between 18 to 40 years Consent form signed Patient of the dermatology department with non-pathological forearm skin Exclusion Criteria: Allergy or intolerance to immersion oil (used for microscopy) If female, pregnant or breast-feeding Patient unable to stand still for 60 seconds

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Luc PERROT, MD

Organizational Affiliation

CHU SAINT ETIENNE

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Cécile DUPONT, PhD

Organizational Affiliation

DAMAE Medical

Official's Role

Study Chair

Facility Information:

Facility Name

Chu de Saint Etienne

City

Saint Etienne

ZIP/Postal Code

42000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Optical Coherence Microscopy in Dermato-oncology

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