NCT06985537

Steroid Injection in Idiopathic Granulomatous Mastitis

Efficacy of Ultrasound Guided Intralesional Steroid Injection in Idiopathic Granulomatous Mastitis (IGM)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• Idiopathic Granulomatous Mastitis

Interventions

Type	Name	Description
DRUG	Ultrasound guided intralesional Steroids injection (Triamicinolone)	Radiological guided steroid injection of IGM

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-01-01
• Completion: 2026-02-01
• First posted: 2025-05-22
• Last updated: 2025-05-22