Clinical trial NCT06985537: Steroid Injection in Idiopathic Granulomatous Mastitis
Official title: Efficacy of Ultrasound Guided Intralesional Steroid Injection in Idiopathic Granulomatous Mastitis (IGM)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Idiopathic Granulomatous Mastitis
Keywords: Idiopathic GM
intralesional steroid injection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Granulomatous mastitis (GM) is a rare, non-infectious inflammatory breast condition typically affecting young women within five years of childbirth, often following breastfeeding. Its etiology remains unknown, but histologically, GM is characterized by granulomatous inflammation with the presence of giant cells. Clinically, it presents as a palpable mass, sometimes accompanied by lymph node enlargement, mimicking multifocal breast cancer. The disease may also present with abscesses and fistulas, complicating diagnosis and treatment. Imaging studies such as ultrasound and mammography often reveal irregular masses and hypoechoic nodules, suggesting malignancy. Consequently, biopsy is frequently performed to confirm the diagnosis, revealing chronic lobulitis and granulomas.

Management of GM often begins with anti-inflammatory medications and antibiotics, though these are generally ineffective without proper diagnosis. 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. While steroid injections are effective, they can cause side effects like skin atrophy and hypopigmentation, though these are typically temporary and resolve over time. Steroids' effectiveness in providing symptom relief minimizes the need for more invasive treatments such as surgery

Eligibility criteria: Inclusion Criteria:

* Women diagnosed with IGM confirmed clinically and histopathologically , willing to undergo intralesional steroid treatment.

Exclusion Criteria:

* Patients with active infections.
* Patients on immunosuppressive therapy.
* pregnant women.

Primary outcomes:
measure: Clinical Resolution Rate at 12 Weeks Post-Treatment And Reduction in Size
timeFrame: 12 weeks (±1 week) after intralesional steroid injection per participant
measure: Clinical Resolution Rate at 12 Weeks Post-Treatment and Reduction in Lesion Size
timeFrame: 12 weeks (±1 week) after intralesional steroid injection per participant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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