Longitudinal Spatial Frequency Domain Imaging Study

Study Purpose

Scleroderma (SSc) is an autoimmune disease characterized by fibrosis (or collagen deposition) of the skin and internal organs. The extent of skin fibrosis is an important predictor of internal organ complications and increased mortality. Currently imprecise and subjective methods that varies amongst different doctors for the same patient are available to quantify skin fibrosis in patients, by "pinching" their skin and assessing how thick it is; this is the method used to determine the modified Rodnan skin score (mRSS). Skin thickness and the amount of fibrosis can change over time due to disease progression or in response to therapy. In this research, longitudinal measurements will be taken to determine if spatial frequency domain imaging (SFDI) can detect changes in skin thickness that occur over time in response to therapy or from disease progression in scleroderma patients. This study will compare SFDI with other clinical outcome assessments of skin thickness and fibrosis in scleroderma patients including mRSS, skin biopsy histology, scleroderma skin patient reported outcome (SSPRO), ultrasound, and durometry (durometer measures skin hardness). SFDI information will also be compared with capillaroscopy (allows for non-invasive imaging of the nailfold capillaries) if available from the electronic medical record. If SFDI correlates well with other clinical outcome assessments, it may be used in the future as a rapid, non-invasive tool for monitoring disease activity in scleroderma patients.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

Participants must meet at least one of the following:

- Have SSc as defined by the American College of Rheumatology (SSc subjects only) - Suspected of having SSc based on clinical symptoms as determined by their physician (SSc subjects only) - Defined as a healthy control (does not have SSc or another known disease that in the opinion of the investigator could confound the results)
Exclusion Criteria:
- Diagnosis of skin malignancy within the previous 2 years, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situ.

- Presence of wounds or skin rashes at the site of Spatial frequency domain imaging (SFDI) measurement or skin biopsy.

- Presence of other co-morbid illnesses with an estimated median life expectancy < 5 years.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05672992
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Boston University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Andreea Bujor, MD, PhD
Principal Investigator Affiliation	BU Chobanian & Advesian School of Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Scleroderma

Additional Details

The overall objective of this study is to determine if a light emitting diode (LED) -based SFDI instrument can be used to detect changes in skin thickness over time in SSc patients. Number of subjects: 60 patients with scleroderma and 32 control subjects without scleroderma.Study procedures: All subjects will have 6 areas of the body, right and left fingers, hands, and forearms, measured with an LED-based SFDI instrument every 3 months for the first 12 months and then every 6 months through 36 months. The right and left upper arms of subjects may be measured with the SFDI instrument if subjects are able to comfortably extend their arms. All subjects will have the option to have blood collected for serum at baseline, 12 months, 24 months, and 36 months to investigate serum biomarkers of fibrosis. An optional skin biopsy will be collected from all subjects at baseline, 12 months, 24 months, and 36 months to evaluate histopathological skin changes. Skin biopsies will not be collected from pregnant or lactating subjects, from subjects with a history of an allergic reaction to a local anesthetic, or from subjects who are deemed by the study doctor to be at high risk of small tissue calcification. Scleroderma subjects will be asked to complete the SSPRO questionnaire at baseline and every 3 months for the first 12 months and then every 6 months through 36 months. Scleroderma subjects will have a mRSS performed at baseline and every 3 months for the first 12 months and then every 6 months through 36 months. All subjects will have durometry and ultrasound performed on the right and left forearms at baseline and every 3 months for the first 12 months and then every 6 months through 36 months. Secondary Objectives:

- Assess how SFDI measurements correlate with other clinical measurements of skin thickness such as durometry, ultrasound, and mRSS.

- Assess how SFDI measurements correlate with clinical biochemical and histopathological assessments of skin changes in SSc.

Arms & Interventions

Arms

Experimental: Scleroderma Participants

Participants in this arm will be asked to complete the Fitzpatrick skin type questionnaire to quantify skin tone and will have measurements taken with a colorimeter on the right and left forearms, hands, and fingers to quantify skin tone at the first study visit. Participants will be asked to complete the SSPRO questionnaire at the time of enrollment and every three months for the first 12 months and then every six months until the end of the study. At each study visit, a physician will measure the mRSS, which is a method of quantifying skin fibrosis; SFDI measurements, ultrasound, and durometry will then be done. Skin biopsies will be collected from the forearm of each subject annually. A small amount of blood will also be collected from subjects once per year to explore serum biomarkers of fibrosis.

Active Comparator: Healthy controls

Interventions

Other: - Spatial-frequency domain imaging (SFDI)

SFDI is a method using near-infrared (NIR) light to generate wide field images (>10 x 10 cm) of tissue optical properties (absorption and scattering coefficients) at sub-surface depths of 1-10 mm. With SFDI the tissue surface (skin) is illuminated by a rapid sequence of sinusoidal light patterns of varying spatial frequency and at different optical wavelengths. Collected camera images are then processed to yield maps of sub-surface optical properties.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Boston, Massachusetts

Status

Recruiting

Address

Shapiro Outpatient Rheumatology Clinic at Boston Medical Center

Boston, Massachusetts, 02118

Site Contact

Britte Beaudette-Zlatanova, PhD

[email protected]

617-358-6171

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