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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04270903
Other study ID # MELA-RPE-PHOTOTYPE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 22, 2019
Est. completion date December 20, 2019

Study information

Verified date February 2020
Source Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to assess the signal of melanin using Electron Paramagnetic resonance (EPR). Melanin is a paramagnetic pigment detectable by EPR. Recent advances in instrumentation allows the application of EPR in human beings. The characterization of melanin by EPR could be potentially interesting in the context of melanoma detection and characterization. While another clinical study is currently ongoing aiming at demonstrating the feasibility of the non-invasive detection of the EPR signal of melanin in melanoma patients, it is crucial to have a control group with healthy skin. The aim of the present study is to assess the influence of skin pigmentation of the EPR signal recorded. In the present clinical study, the EPR signal of melanin will be characterized in healthy skin with different phototypes (1-2, 3-4, 5-6) to assess the potential influence of skin pigmentation on the EPR signal.


Description:

Electron paramagnetic resonance (EPR), also known as electron spin resonance (ESR), is a spectrometric method enabling the observation of the absorption of energy by the free radicals contained by a sample immerged in a strong homogenous magnetic field. An EPR spectrum reveals only the presence of paramagnetic centers and can thus only be observed with samples containing lone unpaired electrons. In water-containing biological environments, most of free radicals are very reactive and have a very short life. To detect such species, a strategy is to use extrinsic molecules that will react with these species to form EPR measurable adducts. This technique is called "spin trapping". In contrast, the study of stable free radicals does not require the use of spin-trap agents. Melanins are part of the rare stable biological radicals directly observable with EPR. In practice, melanin is the only endogenous stable radical that can be detected using 1 GHz EPR.

The aim of the present study is to measure the EPR signal recorded from skin with different pigmentations. 45 healthy volunteers will be enrolled:

15 subjects with phototype 1-2, 15 subjects with phototypes 3-4, 15 subjects with phototypes 5-6. The parameters described hereafter will be investigated:

- g factor (resonance condition); expected g=2.005;

- shape of the signal, presence of a shoulder at g=2.01 due to pheomelanin;

- intensity of the signal (signal height, double integration, double integration relative to reference).

This will provide a database for other ongoing studies carried out in patients with suspicious lesion (nevi vs melanoma)


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 20, 2019
Est. primary completion date September 17, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthy volunteers with skin belonging to Phototype I-II, III-IV, V-VI

Exclusion Criteria:

- Subjects under 18 years

- Subjects with pacemakers

- Subjects with non-removable implants with metal or otherwise not known to be MRI-compatible.

- Pregnant women

Study Design


Intervention

Device:
EPR measurement
Subject put in a magnet, magnetic field sweeping around 40 mTesla. Irradiation with a wave with a frequency of 1.1 GHz. A resonator (surface coil) is put at the surface of the skin (arm). The EPR signal is recorded.

Locations

Country Name City State
Belgium Université catholique de Louvain Brussels

Sponsors (1)

Lead Sponsor Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of the EPR signal intensity Signal height / Double integration / Double integration relative to reference signal Through study completion (6 months)
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