Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis

Granulomatous Mastitis Clinical Trial

— MSTIGM  

Official title:

Evaluation of Topical Steroids and Surgical Treatment for Idiopathic Granulomatous Mastitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02959580
• Other study ID #: PUMCH-breast-mastitis
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2017
• Est. completion date: September 2020

Study information

• Verified date: December 2018
• Source: Peking Union Medical College Hospital
• Contact: Yanna Zhang, M.D.
• Phone: 86-10-69158703
• Email: pumchzyn[@]sohu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the clinical response rate of topical steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive topical steroid and the other half will receive local wide surgical excision.

Description:

Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast disease of unknown etiology.It may present with many findings that clinically and radiologically mimic breast cancer.

Although IGM as a disease has been known for nearly four decades, the optimal treatment approach has not been established. Surgical intervention in the form of wide surgical excision was the mainstay of treatment before 1980, and is still performed depending on local expertise and preference.

Currently,surgical treatment and systemic steroid treatment are frequently employed. With the consideration of side effects of longterm systemic (oral) steroid usage, topical steroid without systemic use were assessed and showed satisfactory curative effect. But the data concerning the use of topical steroid therapy are still very limited.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Idiopathic Granulomatous Mastitis

Exclusion Criteria:

• Breast Carcinoma

Related Conditions & MeSH terms

• Granulomatous Mastitis
• Mastitis

Intervention

Drug:
• Hydrocortisone Butyrate
topical use

Procedure:
• extended excision
Lesion extended excision with or without a random breast dermo-glandular flap (BDGF).

Locations

Country	Name	City	State
China	Department of Breast Surgery,Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

Benson JR, Dumitru D. Idiopathic granulomatous mastitis: presentation, investigation and management. Future Oncol. 2016 Jun;12(11):1381-94. doi: 10.2217/fon-2015-0038. Epub 2016 Apr 12. Review. — View Citation

Sheybani F, Naderi HR, Gharib M, Sarvghad M, Mirfeizi Z. Idiopathic granulomatous mastitis: Long-discussed but yet-to-be-known. Autoimmunity. 2016 Jun;49(4):236-9. doi: 10.3109/08916934.2016.1138221. Epub 2016 Feb 1. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical response rate	The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.	six months
Secondary	granulomatous mastitis recurrence		two years