Steroid Injection in Idiopathic Granulomatous Mastitis

Assiut University

Status and phase: Not yet enrolling; Phase 1

Conditions: Idiopathic Granulomatous Mastitis

Treatments: Drug: Ultrasound guided intralesional Steroids injection (Triamicinolone)

Study type: Interventional

Funder types: Other

Identifiers

NCT06985537

Steroid injection in IGM

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Female diagnosed (clinically and histopatgologically) with IGM not pregnant nor immunocompromised

Other group

Description:

Ultrasound guided intralesional injection of steroids (Triamicinolone) (40mg/ml ) at site of IGM inflammatory mass after injection of local anesthesia ,once every month and follow up for 6 to 12 months

Treatment:

Drug: Ultrasound guided intralesional Steroids injection (Triamicinolone)