Malignant Melanoma
Conditions
Brief summary
The purpose of this clinical investigation was to determine the safety and effectiveness of the SciBase III device (Test) designed to help distinguish between malignant melanoma and benign lesions, using electrical impedance spectroscopy (EIS) relative to the histological gold standard (Reference). The purpose of the study is to collect data to support a Pre-market Application(PMA) to obtain Food and Drug Administration(FDA) approval to market the SciBase III Electrical Impedance Spectrometer.
Interventions
SciBase III Electrical Impedance Spectrometer is based on Electrical Impedance Spectroscopy (EIS). EIS is a measure of the overall resistance within a skin tissue, at alternating currents of various frequencies. Enrolled subject will undergo skin measurements with SciBase III Electrical Impedance Spectrometer. The relevant skin lesion(s) will be excised and diagnosed as per routine treatment.
Sponsors
SciBase AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
For inclusion in the study, all subjects had to fulfill all of the following criteria: * Men or women of any ethnic group aged ≥18 years * Primary lesions (i.e., not metastases or recurrent lesions) that the physicians choose to excise. * Lesion ≥ 2 mm in diameter and ≤ 20 mm in diameter * In subjects with multiple skin lesions, all lesions destined for excision must be identified for purposes of study participation. Note: a subject may only be entered into the study once. * The subject is willing and able to read, understand and sign the study specific informed consent form.
Exclusion criteria
Subjects were excluded from the study if they fulfilled any of the following criteria: * Skin surface not measurable, e.g. lesion on a stalk * Skin surface not accessible, e.g. inside ears, under nails * Lesion located on acral skin, e.g. sole or palms. * Lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions. * Lesion on hair-covered areas, e.g. scalp, beards, moustaches or whiskers. * Lesion located on genitalia. * Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized. * Lesion located on mucosal surfaces. * Skin is not intact (measurement area) e.g. bleeding or with clinical noticeable ulceration. * Lesion with foreign matter, e.g. tattoo, splinter * Lesion and/or reference located on acute sunburn.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SciBase Sensitivity and Specificity | Post data lock | This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device: 1. Sensitivity ≥ 0.90 to detect Melanoma 2. Sensitivity - (1-Specificity) \> 0.00 Sensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity | Post data lock | Secondary confirmatory objective included two co-secondary endpoints that were defined similarly to the co-primary endpoints, but used the Secondary definition of dichotomous reference diagnosis. Positive Reference Diagnosis: Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Severe Dysplastic Nevus (High grade dysplasia) Negative Reference Diagnosis: All other skin lesions. |
Countries
Sweden, United States
Participant flow
Recruitment details
Recruitment was conducted at five (5) US investigational sites and at seventeen (17) European investigational sites. Recruitment period 2010-2011. In 2012 the last histological analysis was performed.
Pre-assignment details
Potential study subjects were screened according to the inclusion/exclusion criteria. All study eligible skin lesion(s) were then examined with the investigational device, photographed and removed by an excisional biopsy.
Participants by arm
| Arm | Count |
|---|---|
| Biopsied Skin Lesions Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto | 1,942 |
| Total | 1,942 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen failure | 8 |
| Overall Study | Subjects signed ICF could not be located | 1 |
Baseline characteristics
| Characteristic | Biopsied Skin Lesions |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 443 Participants |
| Age, Categorical Between 18 and 65 years | 1499 Participants |
| Age Continuous | 49.8 years STANDARD_DEVIATION 16.9 |
| Region of Enrollment Europe | 1484 participants |
| Region of Enrollment United States | 458 participants |
| Sex: Female, Male Female | 1013 Participants |
| Sex: Female, Male Male | 929 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 28 / 1,915 |
| serious Total, serious adverse events | 0 / 1,915 |
Outcome results
Primary
SciBase Sensitivity and Specificity
This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device: 1. Sensitivity ≥ 0.90 to detect Melanoma 2. Sensitivity - (1-Specificity) \> 0.00 Sensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma.
Time frame: Post data lock
Population: Biopsied Skin Lesions
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Biopsied Skin Lesions | SciBase Sensitivity and Specificity | SciBase Sensitivity to melanoma | 96.6 Percentage of total lesions |
| Biopsied Skin Lesions | SciBase Sensitivity and Specificity | SciBase Specificity to non-melanoma | 31.4 Percentage of total lesions |
Clopper-Pearson 1-sided
95% CI: [92.6, 100]Clopper-Pearson 2-sided
95% CI: [68.1, 99.8]Clopper-Pearson 2-sided
p-value: <0.000195% CI: [6.6, 25.5]Mixed Models Analysis
Secondary
Sensitivity and Specificity
Secondary confirmatory objective included two co-secondary endpoints that were defined similarly to the co-primary endpoints, but used the Secondary definition of dichotomous reference diagnosis. Positive Reference Diagnosis: Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Severe Dysplastic Nevus (High grade dysplasia) Negative Reference Diagnosis: All other skin lesions.
Time frame: Post data lock