Spatial-Frequency Domain Imaging for Scleroderma

(SFDI Trial)

Overseen By Andreea Bujor, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Disqualifiers: Skin malignancy, Wounds, Life expectancy < 5 years, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how doctors measure skin thickening in people with scleroderma, an autoimmune disease that hardens the skin and internal organs. Instead of the current "pinching" method, the study tests a new tool called spatial-frequency domain imaging (SFDI), which uses light to measure skin collagen levels more accurately. Participants will undergo non-painful SFDI scans, and some may provide skin samples for further analysis. The trial seeks individuals diagnosed with diffuse cutaneous scleroderma within the last 2-5 years or healthy individuals without autoimmune or skin diseases. As an unphased trial, this study offers a chance to contribute to innovative research that could improve diagnostic methods for scleroderma.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that spatial-frequency domain imaging (SFDI) is safe for measuring skin fibrosis in scleroderma patients?

Research has shown that spatial-frequency domain imaging (SFDI) safely checks for skin thickening in scleroderma patients. This thickening results from excessive collagen. In past studies, both healthy individuals and patients used SFDI, and it was well-tolerated with no harmful effects reported. This imaging method does not touch or break the skin, making it a gentle choice for patients. So far, various studies have used SFDI safely, with no evidence of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spatial-frequency domain imaging (SFDI) for scleroderma because it offers a non-invasive way to assess skin changes, which is a significant improvement over traditional biopsies. SFDI uses light to measure the amount of collagen and other molecules in the skin, potentially providing more precise and detailed information about the progression of the disease. Unlike current treatments that primarily focus on managing symptoms, SFDI could help monitor the effectiveness of therapies and guide treatment decisions by offering real-time insights into skin health.

What evidence suggests that spatial-frequency domain imaging is effective for measuring skin fibrosis in scleroderma?

Research has shown that a new method called spatial-frequency domain imaging (SFDI), which participants in this trial will undergo, can effectively measure skin changes in people with scleroderma. Early results indicate that SFDI closely matches the traditional method of checking skin thickness. This new technique uses light to measure changes and proves more accurate than the old "pinch test." SFDI can detect early changes in skin thickness, making it a reliable tool for assessing skin hardening. By providing clear and objective measurements, SFDI offers a promising new way to track the progression of scleroderma. ^{1 2 3 4 6}

Who Is on the Research Team?

Andreea Bujor, MD, PhD

Principal Investigator

BU Chobanian & Advesian School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals diagnosed with diffuse cutaneous scleroderma (DSSc) within the last 2-5 years, as per American College of Rheumatology and LeRoy classification. Healthy participants without SSc or other autoimmune diseases and no skin issues can also join as controls.

Inclusion Criteria

I was diagnosed with scleroderma between 2-5 years ago and it is the widespread type.

I do not have scleroderma, any autoimmune disease, or known skin conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial measurements including SFDI, mRSS, ultrasound, durometry, and optional skin biopsies are conducted

1 week

1 visit (in-person)

Longitudinal Measurement Phase

Participants undergo repeated SFDI, mRSS, ultrasound, and durometry measurements to assess changes in skin thickness and fibrosis

12 months

4 visits (in-person) at 3, 6, 9, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after the main measurement phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spatial-frequency domain imaging (SFDI)

Trial Overview The study tests a non-painful, noninvasive imaging technique called Spatial-frequency domain imaging (SFDI) to measure skin collagen in SSc patients. It aims to be more accurate than current methods for assessing skin fibrosis.

How Is the Trial Designed?

Group I: Scleroderma Participants Experimental Treatment 1 Intervention

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 each study visit, a physician will measure the mRSS and take SFDI measurements. Ultrasound and durometry will then be done. Optional skin biopsies will be collected from the forearm at baseline and 12 months.

Group II: Control Active Control 1 Intervention

Participants in this arm will be asked to complete SFDI and colorimeter measurements.

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10278615/

Spatial frequency domain imaging for the assessment of ... Our results indicate that SFDI is sensitive to skin changes even at an early stage, as we found a significant difference in the measured optical ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37342706/

Spatial frequency domain imaging for the assessment of ... In this study, we evaluated the use of spatial frequency domain imaging (SFDI) as a more quantitative and reliable method for assessing skin fibrosis in SSc ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07090226

Diffuse Cutaneous Scleroderma (DSSc) SFDI Study The primary objective of this study is to validate spatial-frequency domain imaging (SFDI) and related optical techniques as robust, sensitive, and objective ...

4. withpower.com withpower.com/trial/phase-scleroderma-diffuse-1-2023-78186

SFDI Imaging for Scleroderma (SFDI Trial) Research shows that SFDI can detect skin changes in scleroderma patients even at early stages, providing a more reliable and objective assessment compared to ...

5. researchgate.net researchgate.net/publication/370788001_Spatial_frequency_domain_imaging_for_the_assessment_of_scleroderma_skin_involvement

Spatial frequency domain imaging for the assessment of ... The SFDI data were collected at six measurement sites (left and right forearms, hands, and fingers) of eight control subjects and ten SSc ...

6. ctv.veeva.com ctv.veeva.com/study/longitudinal-spatial-frequency-domain-imaging-study

Longitudinal Spatial Frequency Domain Imaging Study (SFDI) This study will compare SFDI with other clinical outcome assessments of skin thickness and fibrosis in scleroderma patients including mRSS, skin ...