Steroid Injection in Idiopathic Granulomatous Mastitis

May 21, 2025 updated by: Aghapy Ghobrial Reda, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Female diagnosed (clinically and histopatgologically) with IGM not pregnant nor immunocompromised
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)
Radiological guided steroid injection of IGM
Other Names:
  • Triamicinolone as (epirelefan ) (ciscortine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Resolution Rate at 12 Weeks Post-Treatment And Reduction in Size
Time Frame: 12 weeks (±1 week) after intralesional steroid injection per participant

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

May 21, 2025

First Posted (Actual)

May 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 21, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Steroid injection in IGM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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