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

NCT07179003 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00010960
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Abscess

Keywords

Breast abscess; Drainage; Photodynamic therapy; Methylene blue

Outcome Measures

Primary Outcomes (1)

• Time to resolution of clinical symptoms

  Clinical symptoms will be scored daily using a standardized questionnaire that includes objective measures of fever, heart rate, and blood pressure, as well as subjective ratings of pain and heat of the breast using a Likert score. Time to resolution of clinical symptoms will be defined as the time from intervention to the first day on which subjects are afebrile and report no pain, redness, or heat of the breast.

  Day 1 post-intervention until resolution of symptoms

Secondary Outcomes (1)

• Abscess volume on ultrasound tomography

  Day 14 post-intervention until resolution

Other Outcomes (3)

• Time to abscess recurrence

  6 months post-intervention

• Time to repeated intervention

  6 months post-intervention

• Rate of abscess cure

  6 months post-intervention

Study Arms (2)

MB-PDT + standard of care

EXPERIMENTAL

Each subject in this arm will receive standard of care breast abscess drainage, methylene blue, lipid emulsion, and laser illumination.

Procedure: Standard of care breast abscess drainage; Drug: Methylene Blue; Drug: Lipid Emulsion; Device: Insertion of optical fiber; Device: Laser illumination; Procedure: Photodynamic therapy

Standard of care

OTHER

Each subject in this arm will receive standard of care abscess drainage

Procedure: Standard of care breast abscess drainage

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.

MB-PDT + standard of care; Standard of care

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.

MB-PDT + standard of care

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.

MB-PDT + standard of care

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.

MB-PDT + standard of care

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.

MB-PDT + standard of care

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.

MB-PDT + standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Methylene Blue; Fat Emulsions, Intravenous; Photochemotherapy

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Emulsions; Colloids; Dosage Forms; Pharmaceutical Preparations; Parenteral Nutrition Solutions; Pharmaceutical Solutions; Solutions; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Central Study Contacts

Timothy M Baran, PhD

CONTACT

585-276-3188; timothy_baran@urmc.rochester.edu

Anna Weiss, MD

CONTACT

585-487-1700

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study includes two arms: (1) standard of care breast abscess drainage and (2) MB-PDT plus standard of care breast abscess drainage.

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)