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NCT05672992 · ClinicalTrials.gov registry record · NA
Longitudinal Spatial Frequency Domain Imaging Study
A NA study of Systemic Scleroderma, sponsored by Boston University.
- Active
- Registry status
- NA
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT05672992 is a NA study of Systemic Scleroderma that is active but no longer recruiting, run by Boston University. The registered enrollment target is 78 participants, above the 35-participant average among 4 other Systemic Scleroderma trials with a reported enrollment target (123% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05672992, a NA study of Systemic Scleroderma, is active but no longer recruiting, sponsored by Boston University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER Spatial-frequency domain imaging (SFDI)
Study Locations (1)
Massachusetts
- Shapiro Outpatient Rheumatology Clinic at Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2023-02-10 |
| Est. Completion | 2028-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05672992
The ClinicalTrials.gov registry entry for NCT05672992 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 35-participant average among 4 other Systemic Scleroderma trials with a reported enrollment target (123% higher). The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Systemic Scleroderma appearing as the primary indexed condition, and to 1 intervention - of which Spatial-frequency domain imaging (SFDI) is the first listed.
NCT05672992 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05672992 about?
NCT05672992 is a clinical study titled "Longitudinal Spatial Frequency Domain Imaging Study". 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...
What is the current status of trial NCT05672992?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 78 participants. The study started on 2023-02-10. Estimated completion is 2028-09.
What conditions does trial NCT05672992 study?
This clinical trial studies the following conditions: Systemic Scleroderma.
What interventions are being tested in trial NCT05672992?
The interventions under investigation include: Spatial-frequency domain imaging (SFDI) (OTHER).
Who is sponsoring clinical trial NCT05672992?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05672992 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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