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NCT07179003 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by University of Rochester.

Not yet
Registry status
Phase 2
Development phase
50
Enrollment target

NCT07179003: Clinical Trial Phase 2 study, sponsored by University of Rochester.

NCT07179003 is a Phase 2 study that has not yet begun recruiting, run by University of Rochester. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07179003, a Phase 2 study, has not yet begun recruiting, sponsored by University of Rochester.

NOT YET RECRUITING
Registry status
Phase 2
Development phase
50 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DRUG Methylene Blue
  • DEVICE Insertion of optical fiber
  • PROCEDURE Standard of care breast abscess drainage
  • DRUG Lipid Emulsion
  • DEVICE Laser illumination

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2026-04
Est. Completion 2031-03
Phase Phase 2
University of Rochester

636 total trials

What is known before NCT07179003 opens enrollment

NCT07179003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 5 interventions - of which Methylene Blue is the first listed.

NCT07179003 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07179003 about?

NCT07179003 is a clinical study titled "A Phase 2 Study of Methylene Blue Photodynamic Therapy for Treatment of Breast Abscesses". 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...

What is the current status of trial NCT07179003?

This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2026-04. Estimated completion is 2031-03.

What interventions are being tested in trial NCT07179003?

The interventions under investigation include: Methylene Blue (DRUG), Insertion of optical fiber (DEVICE), Standard of care breast abscess drainage (PROCEDURE), Lipid Emulsion (DRUG), Laser illumination (DEVICE).

Who is sponsoring clinical trial NCT07179003?

This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07179003's enrollment target sits among peer trials

50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07179003, the US trial registry maintained by the National Library of Medicine. NCT07179003 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.