Steroid Injection in Idiopathic Granulomatous Mastitis
ConditionIdiopathic Granulomatous Mastitis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAssiut University
About this trial
Granulomatous mastitis (GM) is a non-infectious inflammatory breast condition typically affecting young women, often following breastfeeding. Management of GM often begins with anti-inflammatory medications and antibiotics. Steroids, particularly intralesional corticosteroids, are considered the first-line treatment for GM due to their rapid anti-inflammatory and immunosuppressive effects. Steroids help control symptoms such as painful lumps, swelling, and redness. Steroids' effectiveness in providing symptom relief minimizes the need for more invasive treatments such as surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women diagnosed with IGM confirmed clinically and histopathologically , willing to undergo intralesional steroid treatment.
Disqualifiers
Patients with active infections.
Patients on immunosuppressive therapy.
pregnant women.
Trial design
Design model
Single group
Treatments tested in this trial
Ultrasound guided intralesional Steroids injection (Triamicinolone)
DrugRadiological guided steroid injection of IGM
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Female diagnosed (clinically and histopatgologically) with IGM not pregnant nor immunocompromisedOther 1 intervention
Trial outcomes
Primary outcomes
1
Clinical Resolution Rate at 12 Weeks Post-Treatment And Reduction in Size
To evaluate the clinical efficacy of intralesional steroid injections in reducing lesion size and resolving symptoms in patients with IGM. Anti-inflammatory effect: Steroids like triamcinolone reduce the inflammatory response in breast tissue, alleviating pain, swelling, and mass formation. • Immune modulation: As GM is often immune-mediated, steroids suppress the local immune reaction that drives granuloma formation. Anti-inflammatory effect: Steroids like triamcinolone reduce the inflammatory response in the breast tissue, which is the main driver of pain, swelling, and mass formation in GM • Immune modulation: Since GM is often immune-mediated, steroids help by suppressing the local immune reaction that is causing granuloma formation.
Time frame
12 weeks (±1 week) after intralesional steroid injection per participant2
Clinical Resolution Rate at 12 Weeks Post-Treatment and Reduction in Lesion Size
To evaluate the clinical efficacy of intralesional steroid injections in reducing lesion size and resolving symptoms in patients with IGM. Anti-inflammatory effect: Steroids like triamcinolone reduce the inflammatory response in breast tissue, alleviating pain, swelling, and mass formation. • Immune modulation: As GM is often immune-mediated, steroids suppress the local immune reaction that drives granuloma formation. help determine whether the therapeutic effect observed at 12 weeks is maintained or further improved by 24 weeks, offering insight into long-term effectiveness and recurrence risk. help determine whether the therapeutic effect observed at 12 weeks is maintained or further improved by 24 weeks, offering insight into long-term effectiveness and recurrence risk. determine whether the therapeutic effect observed at 12 weeks is maintained or further improved by 24 weeks, offering
Time frame
12 weeks (±1 week) after intralesional steroid injection per participantLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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