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Longitudinal Spatial Frequency Domain Imaging Study (SFDI)

Primary Purpose

Systemic Scleroderma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spatial-frequency domain imaging (SFDI)
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Systemic Scleroderma focused on measuring Spatial frequency domain imaging (SFDI), modified Rodnan skin score (mRSS), Skin biopsy, Skin fibrosis, Scleroderma skin patient reported outcome (SSPRO), Durometry, Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shapiro Outpatient Rheumatology Clinic at Boston Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Scleroderma Participants

Healthy controls

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

SFDI measurements of skin thickness
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
SFDI measurements of skin thickness
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
SFDI measurements of skin thickness
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
SFDI measurements of skin thickness
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
SFDI measurements of skin thickness
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
SFDI measurements of skin thickness
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
SFDI measurements of skin thickness
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms

Secondary Outcome Measures

Serum fibrosis biomarkers, Chemokines that promote fibrosis
Assessed from serum
Serum fibrosis biomarkers, Pro-inflammatory cytokines involved in immune cell migration
Assessed from serum
Serum fibrosis biomarkers, Matricellular proteins
Assessed from serum
histopathological assessments of skin collagen content
Assessed from skin biopsy samples

Full Information

First Posted
December 20, 2022
Last Updated
October 3, 2023
Sponsor
Boston University
Collaborators
Scleroderma Clinical Trials Consortium (SCTC), Fibrosis ARC: Connecting Tissues and Investigators (FCTI ARC)
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1. Study Identification

Unique Protocol Identification Number
NCT05672992
Brief Title
Longitudinal Spatial Frequency Domain Imaging Study
Acronym
SFDI
Official Title
Spatial Frequency Domain Imaging, Comparison of a Novel Method to Quantify Skin Fibrosis With Currently Used Methods in Scleroderma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
Scleroderma Clinical Trials Consortium (SCTC), Fibrosis ARC: Connecting Tissues and Investigators (FCTI ARC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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: 48 patients with scleroderma and 33 control subjects without scleroderma Study procedures: All subjects will have 6 areas of the body, right and left fingers, hands, and upper arms and forearms, measured with an LED-based SFDI instrument every 6 months from baseline through 36 months. 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 6 months through 36 months. Scleroderma subjects will have a mRSS performed at baseline and every 6 months through 36 months. All subjects will have durometry and ultrasound performed on the right and left forearms at baseline and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Scleroderma
Keywords
Spatial frequency domain imaging (SFDI), modified Rodnan skin score (mRSS), Skin biopsy, Skin fibrosis, Scleroderma skin patient reported outcome (SSPRO), Durometry, Ultrasound

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Scleroderma Participants
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Spatial-frequency domain imaging (SFDI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
SFDI measurements of skin thickness
Description
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
Time Frame
baseline
Title
SFDI measurements of skin thickness
Description
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
Time Frame
6 months
Title
SFDI measurements of skin thickness
Description
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
Time Frame
12 months
Title
SFDI measurements of skin thickness
Description
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
Time Frame
18 months
Title
SFDI measurements of skin thickness
Description
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
Time Frame
24 months
Title
SFDI measurements of skin thickness
Description
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
Time Frame
30 months
Title
SFDI measurements of skin thickness
Description
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Serum fibrosis biomarkers, Chemokines that promote fibrosis
Description
Assessed from serum
Time Frame
baseline and every 12 months up to 36 months
Title
Serum fibrosis biomarkers, Pro-inflammatory cytokines involved in immune cell migration
Description
Assessed from serum
Time Frame
baseline and every 12 months up to 36 months
Title
Serum fibrosis biomarkers, Matricellular proteins
Description
Assessed from serum
Time Frame
baseline and every 12 months up to 36 months
Title
histopathological assessments of skin collagen content
Description
Assessed from skin biopsy samples
Time Frame
baseline and every 12 months up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Britte Beaudette-Zlatanova, PhD
Phone
617-358-6171
Email
britte@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andreea Bujor, MD, PhD
Phone
(617) 358-6783
Email
andreea@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreea Bujor, MD, PhD
Organizational Affiliation
BU Chobanian & Advesian School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shapiro Outpatient Rheumatology Clinic at Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Britte Beaudette-Zlatanova, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Longitudinal Spatial Frequency Domain Imaging Study

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