Methylene Blue Photodynamic Therapy for Breast Abscess

Overseen By Timothy M Baran, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Rochester

Disqualifiers: Pregnancy, Lactation, G6PD deficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating breast abscesses, which are painful, swollen areas in the breast. It compares the usual drainage treatment to a new method that adds methylene blue photodynamic therapy (MB-PDT), a type of light-based treatment, to determine if it can alleviate symptoms more quickly. Participants will receive either just the drainage or both the drainage and MB-PDT. Ideal candidates exhibit breast abscess symptoms such as pain and redness and have approval from their primary care team to join the study. The trial aims to determine if the new method can improve treatment outcomes compared to the usual care. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that methylene blue photodynamic therapy (MB-PDT) is generally safe. In some studies, participants experienced no serious side effects and tolerated the treatment well, indicating its safety. Another study confirmed that MB-PDT is safe and practical, with no harmful effects reported. While skin reactions have been noted in other contexts, they were not observed in studies of MB-PDT for treating abscesses. Overall, evidence suggests that MB-PDT is a safe option for treating breast abscesses. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for breast abscess?

Researchers are excited about methylene blue photodynamic therapy (MB-PDT) for breast abscesses because it introduces a new way to tackle the condition. Unlike standard treatments that primarily rely on drainage, MB-PDT uses methylene blue, a dye activated by laser light, which may help to kill bacteria and reduce inflammation. This dual-action approach could offer faster and more effective healing, potentially reducing the need for prolonged antibiotic use. The combination of methylene blue with laser illumination is a novel mechanism that sets it apart from traditional care methods.

What evidence suggests that this trial's treatments could be effective for breast abscess?

Research shows that methylene blue photodynamic therapy (MB-PDT) can effectively kill bacteria in deep tissue infections. Previous studies have found that this therapy can reduce bacteria commonly found in these infections. MB-PDT has been tested in other conditions and has shown to be safe and practical, with no major safety issues reported. In this trial, some participants will receive MB-PDT alongside standard care for breast abscesses, while others will receive only standard care. Although specific data for breast abscesses is still being collected, the mechanism of MB-PDT suggests it could accelerate symptom relief. This therapy might offer a quicker way to heal breast abscesses when combined with standard treatment. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with breast abscesses. Participants must be eligible for standard care, which includes drainage of the abscess. The study will exclude certain people based on criteria not specified here.

Inclusion Criteria

I am 18 years old or older.

I am experiencing symptoms like pain, redness, or warmth in my breast, suggesting an abscess.

My doctor agrees I can try photodynamic therapy and discuss joining a study.

Exclusion Criteria

My heart and lung function is severely impaired.

I need surgery to remove dead tissue.

I have a blood clotting disorder that cannot be corrected.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard of care breast abscess drainage or MB-PDT plus standard of care

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with imaging and symptom resolution assessments

6 months

Follow-up imaging at 14 days post-drainage and every 14 days until resolution

Long-term follow-up

Participants' medical records are reviewed to assess abscess recurrence, need for repeated intervention, and cure status

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Methylene Blue

Trial Overview The trial is testing methylene blue photodynamic therapy (MB-PDT) alongside standard care versus standard care alone in treating breast abscesses. It aims to see if MB-PDT can speed up symptom resolution and improve cure rates.

How Is the Trial Designed?

Group I: Standard of care Experimental Treatment 1 Intervention

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

Group II: MB-PDT + standard of care Experimental Treatment 6 Interventions

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

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07179003

A Phase 2 Study of Methylene Blue Photodynamic Therapy ... Based on the success of this Phase 1 clinical trial, the current study aims to assess efficacy of MB-PDT at the time of breast abscess drainage.

2. withpower.com withpower.com/trial/phase-2-breast-abscess-3-2026-bcc51

Methylene Blue Photodynamic Therapy for Breast Abscess 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8831513/

Effects of patient-specific treatment planning on eligibility ... Antimicrobial photodynamic therapy (PDT) effectively kills bacterial strains found in deep tissue abscess cavities. PDT response hinges on multiple factors, ...

4. pfmjournal.org pfmjournal.org/journal/view.php?doi=10.23838/pfm.2022.00079

Clinical effectiveness and prospects of methylene blue This review focuses on clinical trials of MB-based therapies applied to brain diseases, cancer imaging and diagnosis, infectious diseases such as malaria or ...

5. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.232667

Safety and Feasibility of Photodynamic Therapy for ... MB-PDT was safe and feasible in all 18 participants (mean age, 60.1 years ± 18.3 [SD]; 10 female), with no negative safety outcomes observed for any participant ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10982828/

Safety and Feasibility of Photodynamic Therapy for ... MB-PDT was a safe and feasible adjunct to image-guided percutaneous abscess drainage. Clinical measures indicated a dose-dependent response to ...