drugset / Trial / NCT02240498
Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The objectives of this Phase 1 study are to evaluate the safety and feasibility of methylene-blue-mediated photodynamic therapy (MB-PDT) performed at the time of abscess drainage to treat deep tissue abscesses. Safety will be evaluated by physical examination and imaging and laboratory studies in order to identify adverse events that may be induced by MB-PDT. We hypothesize that MB-PDT will be a safe and feasible intervention for this patient population. Optical measurements will additionally be performed at the abscess wall to determine optical properties and methylene blue uptake.
Timeline
- Start
- 2014-09
- Primary completion
- 2023-09
- Completion
- 2023-09
Publications
- Background Haidaris CG, Foster TH, Waldman DL, Mathes EJ, McNamara J, Curran T. Effective photodynamic therapy against microbial populations in human deep tissue abscess aspirates. Lasers Surg Med. 2013 Oct;45(8):509-16. doi: 10.1002/lsm.22171. Epub 2013 Aug 29.
- Baran TM, Bass DA, Christensen L, Longbine E, Favella MD, Foster TH, Sharma AK. Safety and Feasibility of Photodynamic Therapy for Percutaneous Image-guided Abdominopelvic Abscess Drainage: Phase 1 Trial. Radiology. 2024 Mar;310(3):e232667. doi: 10.1148/radiol.232667.
- Hannan MN, Sharma AK, Baran TM. First in human measurements of abscess cavity optical properties and methylene blue uptake prior to photodynamic therapy by in vivo diffuse reflectance spectroscopy. J Biomed Opt. 2024 Feb;29(2):027002. doi: 10.1117/1.JBO.29.2.027002. Epub 2024 Feb 27.
- Li Z, Hannan MN, Sharma AK, Baran TM. Treatment planning for photodynamic therapy of abscess cavities using patient-specific optical properties measured prior to illumination. Phys Med Biol. 2024 Feb 28;69(5):055031. doi: 10.1088/1361-6560/ad2635.
- Li Z, Hannan MN, Sharma AK, Baran TM. Treatment planning for photodynamic therapy of abscess cavities using patient-specific optical properties measured prior to illumination. medRxiv [Preprint]. 2023 Nov 6:2023.10.23.23297420. doi: 10.1101/2023.10.23.23297420.
- Baran TM, Sharma AK. Photodynamic Therapy of an Abdominal Abscess at the Time of Percutaneous Drainage. Cardiovasc Intervent Radiol. 2023 Sep;46(9):1292-1294. doi: 10.1007/s00270-023-03504-z. Epub 2023 Jul 18. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylene Blue | Diagnostic / imaging agent | 1 mg/ml | Other |
| Background | Intralipid | Other / unclassified | 1 % | Other |