RECRUITING

Intralesional Injection of STS in Treatment of Calcinosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The specific objective of this study is to perform a small, open-label study to assess the safety and efficacy of intralesional, subcutaneous injection of STS on calcinosis symptoms and lesion size in systemic sclerosis (SSc), mixed connective tissue disease (MCTD) and dermatomyositis (DM) patients. Injection will be guided by ultrasound, lesion size assessed by ultrasound, and symptom burden by patient-reported outcome measures.

Official Title

An Open Label Evaluation of Intralesional Injection of Sodium Thiosulfate in the Treatment of Cutaneous or Tendon Calcinosis in Connective Tissue Disease

Quick Facts

Study Start:2025-03-17
Study Completion:2026-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06672822

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinical diagnosis of systemic sclerosis, mixed connective tissue disease or inflammatory myopathy
  2. * Must be over 18 years of age
  3. * Participants must be competent to give informed consent
  4. * Participants must have radiographic evidence (xray or ultrasound) of calcinosis.
  5. * Participants must need symptomatic relief
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Maureen M Laffoon, BS
CONTACT
412-648-7874
laffoonm@pitt.edu

Principal Investigator

Robyn T Domsis, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

UPMC Arthritis and Autoimmunity Center
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Robyn T. Domsic, MD, MPH

  • Robyn T Domsis, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-17
Study Completion Date2026-05-01

Study Record Updates

Study Start Date2025-03-17
Study Completion Date2026-05-01

Terms related to this study

Keywords Provided by Researchers

  • calcinosis

Additional Relevant MeSH Terms

  • Systemic Sclerosis (SSc)
  • Dermatomyositis
  • Mixed Connective Tissue Disease (MCTD)
  • Calcinosis