A Phase 2 Study of Methylene Blue Photodynamic Therapy for Treatment of Breast Abscesses

Conditions

• Breast Abscess

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Standard of care breast abscess drainage — PROCEDURE
  All subjects will receive ultrasound-guided percutaneous abscess drainage in a procedure room. The site will be prepared and dressed following standard of care sterile procedure, and a needle/catheter will be advanced under ultrasound guidance into the abscess. The abscess will be drained by syringe aspiration, and the cavity will be flushed with sterile saline. Aspirated abscess fluid will be delivered to the Clinical Microbiology Laboratory for processing, including bacterial identification and antibiotic susceptibility testing.
• Methylene Blue — DRUG
  Following standard of care breast abscess drainage, for subjects randomized to the photodynamic therapy arm, sterile, clinical-grade methylene blue will be infused into the abscess cavity at a concentration of 100 µg/mL via the same needle/catheter used for drainage. The volume introduced will be matched to the amount of abscess material aspirated during the standard of care drainage. After a 10-minute incubation interval, methylene blue will be aspirated and the cavity flushed with sterile saline to remove methylene blue that has not been taken up by microbes.
• Lipid Emulsion — DRUG
  For subjects randomized to the photodynamic therapy arm, immediately prior to illumination a lipid emulsion will be administered directly to the abscess through the drainage needle/catheter at a concentration of 0.1%. This lipid emulsion will be either Intralipid or Nutrilipid. The lipid emulsion serves to gently distend the cavity, and through light scattering, homogenize the light dose to the walls of the cavity. The volume administered will be matched to the amount of abscess material aspirated during the standard of care drainage. Following laser illumination, the lipid emulsion will be aspirated and the cavity flushed with sterile saline.
• Insertion of optical fiber — DEVICE
  For subjects randomized to the photodynamic therapy arm, a sterile, single-use optical fiber will be advanced to the approximate center of the abscess cavity via the same needle/catheter used for abscess drainage under ultrasound guidance. This will be connected to the clinical laser system via SMA connector for delivery of treatment light.
• Laser illumination — DEVICE
  For subjects randomized to the photodynamic therapy arm, laser illumination for photodynamic therapy will be delivered by a laser system operating at 665 nm (ML7710, Modulight, Tampere, Finland) at a fluence rate of 20 mW/cm\^2. The laser power required to achieve this fluence rate will be calculated based on abscess size. Illumination will be delivered for \~20 minutes, resulting in a total delivered fluence of 25 J/cm\^2.
• Photodynamic therapy — PROCEDURE
  For subjects randomized to the photodynamic therapy arm, the photodynamic therapy procedure comprises the methylene blue, lipid emulsion, insertion of optical fiber, and laser illumination interventions.

Study Details

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.

Key Dates

Start date

Apr 30, 2026

Status verified

Sep 2025

Primary completion

Mar 31, 2031

Completion

Mar 31, 2031

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: MB-PDT + standard of care
  Each subject in this arm will receive standard of care breast abscess drainage, methylene blue, lipid emulsion, and laser illumination.
• Other: Standard of care
  Each subject in this arm will receive standard of care abscess drainage

Primary Outcome Measure

Time to resolution of clinical symptoms [ Time Frame: Day 1 post-intervention until resolution of symptoms ]

Central Contacts

• Timothy M Baran, PhD
  585-276-3188
  [email protected]
• Anna Weiss, MD
  585-487-1700

Locations (1)

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