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Search / Trial NCT05672992

Longitudinal Spatial Frequency Domain Imaging Study

Launched by BOSTON UNIVERSITY · Jan 3, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Spatial Frequency Domain Imaging (Sfdi) Modified Rodnan Skin Score (M Rss) Skin Biopsy Skin Fibrosis Scleroderma Skin Patient Reported Outcome (Sspro) Durometry Ultrasound

ClinConnect Summary

This clinical trial is studying a new imaging technique called Spatial Frequency Domain Imaging (SFDI) to better understand skin thickness in patients with systemic scleroderma (SSc), an autoimmune disease that causes the skin and internal organs to become stiff and thick due to collagen buildup. Currently, doctors measure skin thickness using a method that can be subjective and varies from one doctor to another. This study aims to see if SFDI can provide a more accurate and non-invasive way to track changes in skin thickness over time, whether due to the disease itself or in response to treatment.

To participate in this trial, individuals must either have SSc, be suspected of having SSc based on their symptoms, or be healthy controls without any known diseases that could affect the study results. Participants can expect to undergo several assessments, including SFDI imaging and comparisons with other standard methods used to measure skin thickness and fibrosis. This research could lead to better tools for monitoring scleroderma, making it easier for doctors to manage the condition. If you or a loved one are interested and meet the eligibility criteria, this could be an opportunity to contribute to important research in this area.

Gender

ALL

Eligibility 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.

About Boston University

Boston University, a leading research institution located in Boston, Massachusetts, is dedicated to advancing health sciences through innovative clinical trials and research initiatives. With a strong emphasis on interdisciplinary collaboration, the university leverages its extensive network of experts and state-of-the-art facilities to conduct rigorous clinical studies aimed at improving patient outcomes and addressing pressing health challenges. Boston University is committed to ethical research practices, patient safety, and the dissemination of findings to foster greater understanding and advancements in medical care.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Andreea Bujor, MD, PhD

Principal Investigator

BU Chobanian & Advesian School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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