Status:
NOT_YET_RECRUITING
A Phase 2 Study of Methylene Blue Photodynamic Therapy for Treatment of Breast Abscesses
Lead Sponsor:
University of Rochester
Conditions:
Breast Abscess
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Breast abscesses consist of a localized, walled-off collection of infected fluid within the breast, with symptoms including breast pain and inflammation, as well as nipple discharge, fever, chills, an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2031
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07179003
Start Date
April 1 2026
End Date
March 1 2031
Last Update
September 23 2025
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642