Steroid Injection in Idiopathic Granulomatous Mastitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound guided intralesional Steroids injection (Triamicinolone).
- Who it may be relevant to
- Registry conditions: Idiopathic Granulomatous Mastitis. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of Ultrasound Guided Intralesional Steroid Injection in Idiopathic Granulomatous Mastitis (IGM)
Overview
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
Interventions
- Drug Ultrasound guided intralesional Steroids injection (Triamicinolone)
Radiological guided steroid injection of IGM
Primary outcome measures
- Clinical Resolution Rate at 12 Weeks Post-Treatment And Reduction in Size [Time frame: 12 weeks (±1 week) after intralesional steroid injection per participant]
- Clinical Resolution Rate at 12 Weeks Post-Treatment and Reduction in Lesion Size [Time frame: 12 weeks (±1 week) after intralesional steroid injection per participant]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Han BK, Choe YH, Park JM, Moon WK, Ko YH, Yang JH, Nam SJ. Granulomatous mastitis: mammographic and sonographic appearances. AJR Am J Roentgenol. 1999 Aug;173(2):317-20. doi: 10.2214/ajr.173.2.10430126. PMID 10430126
- Toktas O, Konca C, Trabulus DC, Soyder A, Koksal H, Karanlik H, Kamali Polat A, Ozbas S, Yormaz S, Isik A, Sezgin E, Soran A. A Novel First-Line Treatment Alternative for Noncomplicated Idiopathic Granulomatous Mastitis: Combined Intralesional Steroid Injection with Topical Steroid Administration. Breast Care (Basel). 2021 Apr;16(2):181-187. doi: 10.1159/000507951. Epub 2020 Jun 30. PMID 34012373
- Godazandeh G, Shojaee L, Alizadeh-Navaei R, Hessami A. Corticosteroids in idiopathic granulomatous mastitis: a systematic review and meta-analysis. Surg Today. 2021 Dec;51(12):1897-1905. doi: 10.1007/s00595-021-02234-4. Epub 2021 Feb 15. PMID 33590327
- Erturk TF, Cakir O, Yaprak Bayrak B, Gunes A, Aydemir S, Utkan NZ. Local Steroid Treatment: An Effective Procedure for Idiopathic Granulomatous Mastitis, Including Complicated Cases. J Invest Surg. 2022 Apr;35(4):745-751. doi: 10.1080/08941939.2021.1933272. Epub 2021 Jun 21. PMID 34154493
- Tekgoz E, Colak S, Cinar M, Yilmaz S. Treatment of idiopathic granulomatous mastitis and factors related with disease recurrence. Turk J Med Sci. 2020 Aug 26;50(5):1380-1386. doi: 10.3906/sag-2003-93. PMID 32394683
- Skandarajah A, Marley L. Idiopathic granulomatous mastitis: a medical or surgical disease of the breast? ANZ J Surg. 2015 Dec;85(12):979-82. doi: 10.1111/ans.12929. Epub 2014 Nov 26. PMID 25424519
- Mizrakli T, Velidedeoglu M, Yemisen M, Mete B, Kilic F, Yilmaz H, Ozturk T, Ozaras R, Aydogan F, Perek A. Corticosteroid treatment in the management of idiopathic granulomatous mastitis to avoid unnecessary surgery. Surg Today. 2015 Apr;45(4):457-65. doi: 10.1007/s00595-014-0966-5. Epub 2014 Jul 4. PMID 24993812
- Akcan A, Oz AB, Dogan S, Akgun H, Akyuz M, Ok E, Gok M, Talih T. Idiopathic Granulomatous Mastitis: Comparison of Wide Local Excision with or without Corticosteroid Therapy. Breast Care (Basel). 2014 May;9(2):111-5. doi: 10.1159/000360926. PMID 24944554
Identifiers
NCT: NCT06985537 · Steroid injection in IGM