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

ConditionBreast Abscess

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Lactation

Allergy to contrast media, narcotics, sedatives, atropine or eggs

Necrotic tissue that requires surgical debridement

Trial design

Design model

Parallel

Treatments tested in this trial

Standard of care breast abscess drainage
Procedure/Surgery
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/Surgery
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.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: MB-PDT + standard of careExperimental treatment 6 interventions

Group B: Standard of careOther 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Day 1 post-intervention until resolution of symptoms

Secondary outcomes

Abscess volume on ultrasound tomography

All subjects will receive ultrasound tomography of their breast immediately prior to abscess drainage, immediately following drainage, and at follow-up appointments. Follow-up imaging will occur at 14 days post-drainage, and every 14 days thereafter until abscess resolution. Images will be segmented to identify the abscess cavity and measure its volume in mL.

Time frame

Day 14 post-intervention until resolution

Other outcomes

Time to abscess recurrence

Each subject's electronic medical record will be reviewed at 6 months post-intervention to determine whether there was recurrence of the treated abscess. If there was recurrence, time to recurrence in days will also be recorded.

Time frame

6 months post-intervention

Time to repeated intervention

Each subject's electronic medical record will be reviewed at 6 months post-intervention to determine whether additional procedures were required to manage the treated abscess. If repeated intervention was required, the time from study intervention to repeated intervention in days will also be recorded.

Time frame

6 months post-intervention

Rate of abscess cure

Each subject's electronic medical record will be reviewed at 6 months post-intervention to determine whether there was recurrence of the treated abscess, whether additional procedures were required to manage the treated abscess, and whether clinical symptoms resolved. If over this 6-month period there was no recurrence, no additional procedures were required to manage the abscess, and clinical symptoms resolved, this will be classified as a cure. If any of these conditions are not satisfied, this will be classified as not cured.

Time frame

6 months post-intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

Source ClinicalTrials.gov

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