Safety and Feasibility of Photodynamic Therapy for Percutaneous Image-guided Abdominopelvic Abscess Drainage : Phase 1 Trial
Background Standard-of-care abscess management includes image-guided percutaneous drainage and antibiotics; however, cure rates vary, and concern for antibiotic-resistant bacteria is growing. Photodynamic therapy (PDT), which uses light-activated dyes to generate cytotoxic reactive oxygen species, could complement the standard of care by sterilizing the abscess at the time of drainage. Purpose To evaluate safety and feasibility of PDT with methylene blue (hereafter, MB-PDT) at the time of percutaneous abscess drainage. Materials and Methods This prospective, open-label, dose-escalation, first-in-humans, registered phase 1 clinical study of MB-PDT included participants who underwent percutaneous abdominal or pelvic abscess drainage with CT or US guidance from January 2015 to March 2020 and September 2022 to September 2023. Following drainage, MB-PDT was performed with laser illumination at a fluence rate of 20 mW/cm2, with fluence groups of 6, 12, 18, 24, 30, and 36 J/cm2 (n = 3 each). The primary outcome was safety, indicated by absence of fat embolism, MB escape, abscess wall damage, and need for surgery to remove optical fibers. Preliminary efficacy end points included the time to drainage catheter removal, drainage catheter output volume, and clinical symptom and fever duration. Relationships between fluence and outcomes were analyzed with Spearman correlation and linear regression analyses, and ordinary one-way analysis of variance was used for group comparisons. Results 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. No study-related adverse events were encountered, and the procedure did not increase reported pain (P = .1). Clinical symptom and fever duration was shorter in participants receiving higher fluences (30 and 36 J/cm2 vs 6 J/cm2) (P = .03). The presence of antibiotic-resistant bacteria was not predictive of clinical symptom and fever duration (β = 0.13, P = .37). Conclusion MB-PDT was a safe and feasible adjunct to image-guided percutaneous abscess drainage. Clinical measures indicated a dose-dependent response to PDT. ClinicalTrials.gov registration no.: NCT02240498 © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Johnston and Goldberg in this issue.
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:310 |
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| Enthalten in: |
Radiology - 310(2024), 3 vom: 22. März, Seite e232667 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Baran, Timothy M [VerfasserIn] |
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Date Completed 20.03.2024 Date Revised 22.04.2024 published: Print ClinicalTrials.gov: NCT02240498 UpdateOf: medRxiv. 2023 Oct 16;:. - PMID 37904931 Citation Status MEDLINE |
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| doi: |
10.1148/radiol.232667 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 520 | |a Background Standard-of-care abscess management includes image-guided percutaneous drainage and antibiotics; however, cure rates vary, and concern for antibiotic-resistant bacteria is growing. Photodynamic therapy (PDT), which uses light-activated dyes to generate cytotoxic reactive oxygen species, could complement the standard of care by sterilizing the abscess at the time of drainage. Purpose To evaluate safety and feasibility of PDT with methylene blue (hereafter, MB-PDT) at the time of percutaneous abscess drainage. Materials and Methods This prospective, open-label, dose-escalation, first-in-humans, registered phase 1 clinical study of MB-PDT included participants who underwent percutaneous abdominal or pelvic abscess drainage with CT or US guidance from January 2015 to March 2020 and September 2022 to September 2023. Following drainage, MB-PDT was performed with laser illumination at a fluence rate of 20 mW/cm2, with fluence groups of 6, 12, 18, 24, 30, and 36 J/cm2 (n = 3 each). The primary outcome was safety, indicated by absence of fat embolism, MB escape, abscess wall damage, and need for surgery to remove optical fibers. Preliminary efficacy end points included the time to drainage catheter removal, drainage catheter output volume, and clinical symptom and fever duration. Relationships between fluence and outcomes were analyzed with Spearman correlation and linear regression analyses, and ordinary one-way analysis of variance was used for group comparisons. Results 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. No study-related adverse events were encountered, and the procedure did not increase reported pain (P = .1). Clinical symptom and fever duration was shorter in participants receiving higher fluences (30 and 36 J/cm2 vs 6 J/cm2) (P = .03). The presence of antibiotic-resistant bacteria was not predictive of clinical symptom and fever duration (β = 0.13, P = .37). Conclusion MB-PDT was a safe and feasible adjunct to image-guided percutaneous abscess drainage. Clinical measures indicated a dose-dependent response to PDT. ClinicalTrials.gov registration no.: NCT02240498 © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Johnston and Goldberg in this issue | ||
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| 700 | 1 | |a Foster, Thomas H |e verfasserin |4 aut | |
| 700 | 1 | |a Sharma, Ashwani K |e verfasserin |4 aut | |
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