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SFDI Imaging for Scleroderma (SFDI Trial)

N/A
Recruiting
Led By Andreea Bujor, MD, PhD
Research Sponsored by Boston University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have SSc as defined by the American College of Rheumatology (SSc subjects only)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and every 12 months up to 36 months
Awards & highlights

SFDI Trial Summary

This trial will compare SFDI to other measures of skin thickness and fibrosis in people with scleroderma, to see if SFDI can be used as a fast, non-invasive way to monitor disease activity.

Who is the study for?
This trial is for individuals with systemic scleroderma, or those suspected of having it based on symptoms. Healthy controls without scleroderma or diseases that could affect results can also join. Participants shouldn't have skin wounds, rashes where imaging will be done, a recent skin cancer diagnosis (except certain treated cases), or illnesses with life expectancy under 5 years.Check my eligibility
What is being tested?
The study tests if spatial frequency domain imaging (SFDI) can accurately monitor changes in skin thickness and fibrosis over time in scleroderma patients. It compares SFDI to current methods like the modified Rodnan skin score, biopsies, patient reports, ultrasound, durometry and capillaroscopy.See study design
What are the potential side effects?
Since SFDI is a non-invasive imaging technique used to measure properties of the skin without any physical intervention into the body's internal structures, there are no direct side effects associated with its use.

SFDI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with systemic sclerosis.

SFDI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and every 12 months up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every 12 months up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SFDI measurements of skin thickness
Secondary outcome measures
Serum fibrosis biomarkers, Chemokines that promote fibrosis
Serum fibrosis biomarkers, Matricellular proteins
Serum fibrosis biomarkers, Pro-inflammatory cytokines involved in immune cell migration
+1 more

SFDI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Scleroderma ParticipantsExperimental Treatment1 Intervention
Participants in this arm will be asked to complete the Fitzpatrick skin type questionnaire to quantify skin tone at the first study visit and the SSPRO questionnaire at the time of enrollment and 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.
Group II: Healthy controlsActive Control1 Intervention
Participants in this arm will be asked to complete the Fitzpatrick skin type questionnaire to quantify skin tone at the first study visit. At each study visit, SFDI measurements, ultrasound, and durometry will 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.

Find a Location

Who is running the clinical trial?

Boston UniversityLead Sponsor
454 Previous Clinical Trials
9,941,489 Total Patients Enrolled
Fibrosis ARC: Connecting Tissues and Investigators (FCTI ARC)UNKNOWN
Scleroderma Clinical Trials Consortium (SCTC)UNKNOWN

Media Library

Scleroderma Participants Clinical Trial Eligibility Overview. Trial Name: NCT05672992 — N/A
Systemic Scleroderma Research Study Groups: Scleroderma Participants, Healthy controls
Systemic Scleroderma Clinical Trial 2023: Scleroderma Participants Highlights & Side Effects. Trial Name: NCT05672992 — N/A
Scleroderma Participants 2023 Treatment Timeline for Medical Study. Trial Name: NCT05672992 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacant spots available for inclusion in this trial?

"Contrary to what is reported on clinicaltrials.gov, this trial has concluded its recruitment process; it was first posted on February 1st of 2023 and the last update took place three months later. However, 78 other studies are still seeking patients for their trials."

Answered by AI

Who else is applying?

What state do they live in?
California
North Carolina
Virginia
Other
What site did they apply to?
Shapiro Outpatient Rheumatology Clinic at Boston Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Longitudinal Spatial Frequency Domain Imaging Study
2023. "Longitudinal Spatial Frequency Domain Imaging Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05672992.
All > Scleroderma Research Foundation > Scleroderma
~52 spots leftby Jun 2026
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