International Melanoma Algorithm Training Study - IMATS

Malignant Melanoma Clinical Trial

Official title:

An International, Multicenter, Prospective, Non-controlled, Non-randomised, Clinical Study to Collect Impedance Data of Potentially Malignant Pigmented Nevi and Histological Diagnoses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966173
• Other study ID #: 6001
• Status: Completed
• Phase: N/A
• First received: August 25, 2009
• Last updated: August 10, 2010
• Start date: December 2005
• Est. completion date: July 2010

Study information

• Verified date: August 2010
• Source: SciBase AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

This is an international, multicenter, prospective, non controlled, non randomized, clinical study to collect electrical impedance data of potentially malignant pigmented nevi and histological diagnoses (International Melanoma Algorithm Training Study [IMATS]). The study objective is to collect data for training and optimization of an algorithm that can classify skin lesions using electrical impedance, i.e., to identify malignant melanomas.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women of any ethnic group

• Lesion located on normal healthy skin

• Maximum number of eight lesions per patient

• etc.

Exclusion Criteria:

• Lesion under finger and toe nails

• Lesion located on eczema, psoriasis areas or similar

• Lesion located on scars

• etc.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Device:
• SciBase III Electrical Impedance Spectrometer
Following enrollment, patients will undergo measurements with SciBase III Electrical Impedance Spectrometer. Electrical impedance of the skin will be measured with a microinvasive spiked probe.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital, Dpt. of Dermatology	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
SciBase AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome measure not applicable. This is an algorithm training study.		Q1 2010	No