Idiopathic Granulomatous MastitisPhase 1NCT06985537
Steroid Injection in Idiopathic Granulomatous Mastitis
A Phase 1 study testing Ultrasound guided intralesional Steroids injection (Triamicinolone) in people with Idiopathic Granulomatous Mastitis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Idiopathic Granulomatous Mastitis
- What is being tested?
- Ultrasound guided intralesional Steroids injection (Triamicinolone)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Feb 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with IGM confirmed clinically and histopathologically , willing to undergo intralesional steroid treatment.
Who cannot join
- Patients with active infections.
- Patients on immunosuppressive therapy.
- pregnant women.
About this study
Official title: 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.
Read the 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
- Conditions
- Idiopathic Granulomatous Mastitis
- Being tested
- Ultrasound guided intralesional Steroids injection (Triamicinolone)
- Keywords
- Idiopathic GM, intralesional steroid injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided intralesional Steroids injection (Triamicinolone)Drug
Also called Triamicinolone as (epirelefan ) (ciscortine)
Radiological guided steroid injection of IGM
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ultrasound guided intralesional Steroids injection (Triamicinolone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 weeks (±1 week) after intralesional steroid injection per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study startJun 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Granulomatous MastitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aghapy Ghobrial Reda, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985537
- Sponsor's protocol ID
- Steroid injection in IGM
- Status last verified
- May 2025
- First submitted
- 11 Dec 2024
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 10430126Toktas 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.
PubMed 34012373Godazandeh 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.
PubMed 33590327Erturk 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.
PubMed 34154493Tekgoz 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.
PubMed 32394683Skandarajah 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.
PubMed 25424519Mizrakli 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.
PubMed 24993812Akcan 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.
PubMed 24944554Altintoprak 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.
PubMed 26148520Chirappapha 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.
PubMed 30479764
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound Guided Intralesional Steroid Injection in Idiopathic Granulomatous Mastitis (IGM)
- ClinicalTrials.gov ID
- NCT06985537
- Acronym / sponsor ID
- Steroid injection in IGM
- Conditions
- Idiopathic Granulomatous Mastitis
- Keywords
- Idiopathic GM, intralesional steroid injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female diagnosed (clinically and histopatgologically) with IGM not pregnant nor immunocompromised | Other | Drug: Ultrasound guided intralesional Steroids injection (Triamicinolone)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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women diagnosed with IGM confirmed clinically and histopathologically , willing to undergo intralesional steroid treatment.
Key exclusion criteria (3 listed)
- Patients with active infections.
- Patients on immunosuppressive therapy.
- pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided intralesional Steroids injection (Triamicinolone)Also: Triamicinolone as (epirelefan ) (ciscortine)Radiological guided steroid injection of IGM | Drug | Female diagnosed (clinically and histopatgologically) with IGM not pregnant nor immunocompromised |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Background: PubMed 10430126Han 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.
- Background: PubMed 34012373Toktas 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.
- Background: PubMed 33590327Godazandeh 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.
- Background: PubMed 34154493Erturk 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.
- Background: PubMed 32394683Tekgoz 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.
- Background: PubMed 25424519Skandarajah 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.
- Background: PubMed 24993812Mizrakli 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.
- Background: PubMed 24944554Akcan 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.
- Background: PubMed 26148520Altintoprak 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.
- Background: PubMed 30479764Chirappapha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ultrasound guided intralesional Steroids injection (Triamicinolone) in people with Idiopathic Granulomatous Mastitis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Resolution Rate at 12 Weeks Post-Treatment And Reduction in Size (time frame: 12 weeks (±1 week) after intralesional steroid injection per participant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06985537, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.