A Phase 2 Study of Methylene Blue Photodynamic Therapy for Treatment of Breast Abscesses (NCT07179003) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase 2 Study of Methylene Blue Photodynamic Therapy for Treatment of Breast Abscesses
United States50 participantsStarted 2026-04
Plain-language summary
The objective of this Phase 2 study is to evaluate the efficacy of methylene blue photodynamic therapy (MB-PDT) performed at the time of percutaneous breast abscess drainage for disinfection of breast abscesses. The study includes two arms: (1) standard of care breast abscess drainage and (2) MB-PDT plus standard of care breast abscess drainage. The primary endpoint is time to resolution of clinical symptoms. Secondary endpoints include imaging evidence of abscess resolution, abscess recurrence, need for repeated intervention, and cure rate across treatment groups. Responses will be compared between the two study arms for the per protocol population to determine the efficacy of MB-PDT relative to standard of care. The investigators hypothesize that the addition of MB-PDT to standard of care will significantly reduce the time to symptom resolution, compared to standard of care alone.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults 18 years or older
* Clinical signs of breast abscess, including pain, redness, and/or heat of the breast
* Approval by the primary care team to pursue PDT and discuss enrollment with the patient
Exclusion Criteria:
* Pregnancy
* Lactation
* Allergy to contrast media, narcotics, sedatives, atropine or eggs
* Necrotic tissue that requires surgical debridement
* Severely compromised cardiopulmonary function or hemodynamic instability
* Thrombocytopenia (\<50,000/mm3)
* Uncorrectable coagulopathy
* Poor kidney function (serum creatinine \>3mg/dl)
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Patients with hidradenitis suppurativa
* Patients with granulomatous mastitis
* Unable or unwilling to understand or to provide informed consent
* Unable or unwilling to undergo study procedures
* Patient unable to cooperate with, or to be positioned for the procedure
* Unable to comply with necessary follow up
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to resolution of clinical symptoms
Timeframe: Day 1 post-intervention until resolution of symptoms