An observational study in Non-Puerperal Mastitis, sponsored by Song Hongping. Recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Song Hongping · Observational
The goal of this prospective registry cohort study is to evaluate the efficacy and quality-of-life impact of ablation therapy in patients with non-puerperal mastitis. The main questions it aims to answer are:
Does ablation therapy effectively control inflammation in patients with non-puerperal mastitis?
Does ablation therapy lead to a superior quality of life compared to standard treatments?
Researchers will compare patients receiving ablation therapy to those receiving oral medication or surgery to see if ablation provides better inflammatory control and improves patients' quality of life.
Participants will undergo their assigned treatment (ablation, oral medication, or surgery) and be asked to complete regular follow-up visits and quality-of-life questionnaires over a long-term period.
Background: Non-puerperal mastitis is a chronic inflammatory breast disease with high recurrence rate. This single-center prospective observational cohort aims to compare clinical outcomes between ablation therapy and other real-world treatments for non-puerperal mastitis. Eligible female patients with pathologically-confirmed non-puerperal mastitis will receive clinical-decision-driven therapies including ablation, glucocorticoids, anti-tuberculosis agents, surgical resection or basic symptomatic care. All participants will be followed-up for 24 months. Clinical efficacy is evaluated by M-score; patient-reported quality of life is assessed using the BREAST-Q questionnaire. Stratified analyses will be performed to compare outcomes across different treatment groups.
31 studies on the registry are indexed under Mastitis; 7 are open to participants now.
This study's planned enrollment of 340 is above the median of 211 across 14 observational studies indexed under Mastitis.
Browse Mastitis studies →Song Hongping is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
This single-center study will prospectively enroll female patients aged 18 years or older with a pathologically confirmed diagnosis of non-puerperal mastitis via core needle biopsy at the First Affiliated Hospital of Air Force Medical University.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving ablation therapy for non-puerperal mastitis.
Procedure: Ablation
Patients receiving treatments other than ablation therapy include glucocorticoid therapy, anti-tuberculosis therapy, surgical resection and basic symptomatic treatment.
Other: Observation
Under real-time ultrasound guidance, an ablation needle (radiofrequency electrode, microwave antenna, or laser fiber) is precisely punctured into the center of the lesion. The corresponding energy generator is then connected with parameters configured, and energy delivery is initiated to rapidly raise local tissue temperature above 60 °C, inducing coagulative necrosis of cells via thermal biological effects. The ablation zone is continuously monitored by imaging during the procedure; needle position or parameters are adjusted when necessary to ensure complete lesion coverage. Energy output is terminated once the pre-set ablation margin is achieved, and the ablation needle is withdrawn.
Basic symptomatic treatment: Patients receive symptomatic care. Glucocorticoid therapy: Prednisone (5 mg), methylprednisolone (4 mg) or prednisone acetate (5 mg) starts at 0.5 mg/(kg·d). After 2-week maintenance, doses are gradually tapered; low-dose maintenance (2.5-5.0 mg/d) continues 4-8 weeks per symptoms and tolerability. Anti-tuberculosis therapy: Oral rifampicin, isoniazid and ethambutol for 6-9 months. Surgical resection: Pre-operative ultrasound maps lesions. Local or general anesthesia is used. Inflammatory lesions and sinus tracts are completely excised with maximal preservation of normal breast parenchyma.Intra-operative hemostasis and saline irrigation are done; primary closure or open drainage depends on wound status. Post-operative symptomatic care and wound dressing are provided.
Also known as: drug, surgery
1-year complete remission
Complete disappearance of clinical symptoms and complete resolution of target lesions on imaging evaluation within 1 year.
Time frame: From enrollment up to 1 year post-treatment completion
Time to Complete Remission
Complete disappearance of clinical symptoms and complete resolution of target lesions on imaging evaluation.
Time frame: From enrollment up to 1 year post-treatment completion
1-Year Partial Response
Improvement in all clinically significant symptoms, including pain, swelling, erythema, and induration, within 1 year; OR at least a 30% decrease in the sum of target lesion diameters relative to the baseline sum.
Time frame: From enrollment up to 1 year post-treatment completion
1-Year Overall Response
Achieving either complete remission (CR) or partial remission (PR) criteria within 1 year.
Time frame: From enrollment up to 1 year post-treatment completion
Non-Response
Target lesion shrinkage is insufficient to meet PR criteria, or disease progression, new ulceration, or fistula formation occurs during treatment.
Time frame: From enrollment up to 1 year post-treatment completion
Recurrence Rate
Disease recurrence 3 months after achieving clinical and ultrasound-confirmed complete remission.
Time frame: From enrollment up to 3 month post-treatment completion
Time to Recurrence
Disease recurrence 3 months after achieving clinical and ultrasound-confirmed complete remission.
Time frame: From enrollment up to 3 month post-treatment completion
M-SCORE
a clinical severity scoring system for non-puerperal mastitis, consisting of mass, erythema, pain, fistula and abscess subscores. Higher scores indicate more severe disease.
Time frame: From enrollment up to 1 year post-treatment completion
Breast satisfaction (BREAST-Q score)
a validated patient-reported outcome questionnaire to assess breast satisfaction, psychosocial well-being, physical well-being and sexual well-being. Scores range from 0 to 100; higher scores indicate better patient-reported outcomes.
Time frame: From enrollment up to 1 year post-treatment completion
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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