Steroid Injection in Idiopathic Granulomatous Mastitis

NCT06985537 | Not Yet Recruiting Phase 1

• 1 other identifier: Steroid injection in IGM
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Idiopathic Granulomatous Mastitis

Keywords

Idiopathic GM; intralesional steroid injection

Outcome Measures

Primary Outcomes (2)

• 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.

  12 weeks (±1 week) after intralesional steroid injection per participant

• 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

  12 weeks (±1 week) after intralesional steroid injection per participant

Study Arms (1)

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

OTHER

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

Drug: Ultrasound guided intralesional Steroids injection (Triamicinolone)

Interventions

Ultrasound guided intralesional Steroids injection (Triamicinolone) DRUG

Radiological guided steroid injection of IGM

Also known as: Triamicinolone as (epirelefan ) (ciscortine)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Altintoprak F, Kivilcim T, Yalkin O, Uzunoglu Y, Kahyaoglu Z, Dilek ON. Topical Steroids Are Effective in the Treatment of Idiopathic Granulomatous Mastitis. World J Surg. 2015 Nov;39(11):2718-23. doi: 10.1007/s00268-015-3147-9.

  PMID: 26148520 BACKGROUND

• Chirappapha P, Thaweepworadej P, Supsamutchai C, Biadul N, Lertsithichai P. Idiopathic granulomatous mastitis: A retrospective cohort study between 44 patients with different treatment modalities. Ann Med Surg (Lond). 2018 Nov 9;36:162-167. doi: 10.1016/j.amsu.2018.11.001. eCollection 2018 Dec.

  PMID: 30479764 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal investigator

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: May 22, 2025
• Study Start: June 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05