Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06052956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-09-18
Brief Title:
Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
A Phase 2 Study to Assess Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 abscess drainage for disinfection of deep tissue abscesses The study includes three arms 1 MB-PDT at a fixed druglight dose plus standard of care abscess drainage 2 MB-PDT at a patient-specific dose determined by pre-treatment optical measurements plus standard of care abscess drainage and 3 standard of care abscess drainage The primary endpoint is reduction in bacterial burden from pre- to post-intervention quantified by culture of abscess aspirates
Detailed Description:
Abscesses form as a result of the interaction between an acute microbial infection and the host immune system and generally result in fever nausea and acute abdominal pain If untreated the mortality rate can be high Abscesses are routinely managed by image-guided percutaneous drainage and delivery of systemic antibiotics Despite this standard of care abscesses remain a significant source of morbidity mortality and hospital stay Further response can vary widely between patients Many abscesses also contain antibiotic resistant species
Photodynamic therapy PDT which relies upon the combination of photosensitive dyes known as photosensitizers excitation by visible light and molecular oxygen to generate cytotoxic reactive oxygen species represents a powerful adjunct to standard of care drainage A Phase 1 clinical trial aimed at assessing the safety and feasibility of methylene blue MB PDT at the time of percutaneous abscess drainage ClinicalTrialsgov Identifier NCT02240498 was completed No adverse or serious adverse events were observed and the procedure was well tolerated by all subjects However this Phase 1 study was not designed or adequately powered to evaluate efficacy of MB-PDT and did not include objective assessment of treatment efficacy The current study therefore aims to assess efficacy of MB-PDT by analysis of pre- and post-PDT samples
This is a single center randomized open-label Phase 2 clinical trial which will be conducted in accordance with the principles of good clinical practice and following approval by both the FDA and local IRB Patients who have been diagnosed with a drainable abscess that meet all inclusionexclusion criteria and have the approval of their primary care team will be offered enrollment in the study Consented subjects will be assigned prospectively to one of three arms 1 MB-PDT at a fixed druglight dose plus standard of care abscess drainage 2 MB-PDT at a patient-specific dose determined by pre-treatment optical measurements plus standard of care abscess drainage and 3 standard of care abscess drainage alone The primary endpoint is reduction in bacterial burden from pre- to post-intervention Secondary endpoints include change in white blood cell count and blood cultures from pre-intervention to 24 hours post-intervention drain output following intervention and resolution of clinical symptoms
All subjects will receive standard of care image-guided percutaneous abscess drainage This includes collection of a pre-intervention abscess aspirate sample and placement of a drainage catheter
For subjects in Arms 1 and 2 sterile methylene blue MB will then be administered to the abscess cavity using the same needlecatheter utilized for standard of care drainage After a 10 minute incubation interval MB will be aspirated and the cavity flushed with sterile saline
For subjects in Arm 2 optical spectroscopy measurements will then be made to determine the optical properties of the abscess wall This will be done by connecting the proximal end of the sterile optical fiber used for treatment illumination to a custom optical spectroscopy system The distal end of this fiber will be advanced through the same catheterneedle used for the standard of care procedure in order to make gentle contact with the wall of the cavity Low-intensity white light will be delivered by the fiber and light that has interacted with the abscess wall will be detected by the same optical fiber These optical measurements will be averaged and used to extract the absorption and reduced scattering coefficients at the treatment wavelength These extracted optical properties along with the subjects segmented pre-procedure CT images will be used to generate a patient-specific treatment plan that seeks to deliver a desired fluence rate to 95 of the abscess wall while limiting the portion of the abscess wall that receives a high fluence rate 400 mWcm2 to less than 5
For subjects in Groups 1 and 2 the cavity will then be filled with sterile 01 lipid emulsion solution to gently distend the cavity and through efficient light scattering homogenize the light dose to the walls of the cavity A sterile optical fiber will be advanced to the approximate center of the abscess cavity via the same catheterneedle under image guidance The proximal end of the fiber is coupled to the output of a diode laser system emitting light at 665 nm
For subjects in Group 1 MB-PDT at a fixed dose laser power will be delivered to the cavity at a constant fluence rate The laser power required to obtain the desired fluence rate at the wall will be calculated purely based on the abscess size For subjects in Group 2 MB-PDT with patient-specific treatment planning the subjects measured optical properties and their segmented pre-procedure CT images will be integrated with treatment planning software to determine the laser power required to deliver the desired fluence rate to 95 of the abscess wall while limiting the portion of the abscess wall that receives a fluence rate of 400 mWcm2 to less than 5 In both cases illumination will be delivered for 20 minutes resulting in a total delivered fluence of 24 Jcm2 Immediately after laser irradiation the Intralipid solution will be aspirated and the cavity again flushed with sterile saline
Collection of aspirated abscess material for microbiological assessment is standard of care for percutaneous abscess drainage A portion of this standard of care collection will be collected by the study team for additional quantitative evaluation Additionally a post-intervention aspirate sample will be collected for study purposes For subjects in Groups 1 and 2 MB-PDT this sample will consist of the aspirated saline used to flush the abscess cavity after Intralipid aspiration For subjects in Group 3 this sample will consist of the aspirated saline used to flush the cavity following drainage
If successful this research could result in an adjunct treatment for abscess patients that improves long-term abscess resolution and the rate of response to percutaneous drainage This clinical strategy would offer a wide range of potential health benefits to patients with deep tissue abscess Among these advantages are reduced surgical intervention decreased spread of infection shortened course of post-treatment antibiotic therapy and decreased selective pressure for antibiotic resistance Ultimately this would promote early recovery shorten hospital stay and lead to lower overall health care costs for patients undergoing image-guided percutaneous abscess drainage
Photodynamic therapy PDT which relies upon the combination of photosensitive dyes known as photosensitizers excitation by visible light and molecular oxygen to generate cytotoxic reactive oxygen species represents a powerful adjunct to standard of care drainage A Phase 1 clinical trial aimed at assessing the safety and feasibility of methylene blue MB PDT at the time of percutaneous abscess drainage ClinicalTrialsgov Identifier NCT02240498 was completed No adverse or serious adverse events were observed and the procedure was well tolerated by all subjects However this Phase 1 study was not designed or adequately powered to evaluate efficacy of MB-PDT and did not include objective assessment of treatment efficacy The current study therefore aims to assess efficacy of MB-PDT by analysis of pre- and post-PDT samples
This is a single center randomized open-label Phase 2 clinical trial which will be conducted in accordance with the principles of good clinical practice and following approval by both the FDA and local IRB Patients who have been diagnosed with a drainable abscess that meet all inclusionexclusion criteria and have the approval of their primary care team will be offered enrollment in the study Consented subjects will be assigned prospectively to one of three arms 1 MB-PDT at a fixed druglight dose plus standard of care abscess drainage 2 MB-PDT at a patient-specific dose determined by pre-treatment optical measurements plus standard of care abscess drainage and 3 standard of care abscess drainage alone The primary endpoint is reduction in bacterial burden from pre- to post-intervention Secondary endpoints include change in white blood cell count and blood cultures from pre-intervention to 24 hours post-intervention drain output following intervention and resolution of clinical symptoms
All subjects will receive standard of care image-guided percutaneous abscess drainage This includes collection of a pre-intervention abscess aspirate sample and placement of a drainage catheter
For subjects in Arms 1 and 2 sterile methylene blue MB will then be administered to the abscess cavity using the same needlecatheter utilized for standard of care drainage After a 10 minute incubation interval MB will be aspirated and the cavity flushed with sterile saline
For subjects in Arm 2 optical spectroscopy measurements will then be made to determine the optical properties of the abscess wall This will be done by connecting the proximal end of the sterile optical fiber used for treatment illumination to a custom optical spectroscopy system The distal end of this fiber will be advanced through the same catheterneedle used for the standard of care procedure in order to make gentle contact with the wall of the cavity Low-intensity white light will be delivered by the fiber and light that has interacted with the abscess wall will be detected by the same optical fiber These optical measurements will be averaged and used to extract the absorption and reduced scattering coefficients at the treatment wavelength These extracted optical properties along with the subjects segmented pre-procedure CT images will be used to generate a patient-specific treatment plan that seeks to deliver a desired fluence rate to 95 of the abscess wall while limiting the portion of the abscess wall that receives a high fluence rate 400 mWcm2 to less than 5
For subjects in Groups 1 and 2 the cavity will then be filled with sterile 01 lipid emulsion solution to gently distend the cavity and through efficient light scattering homogenize the light dose to the walls of the cavity A sterile optical fiber will be advanced to the approximate center of the abscess cavity via the same catheterneedle under image guidance The proximal end of the fiber is coupled to the output of a diode laser system emitting light at 665 nm
For subjects in Group 1 MB-PDT at a fixed dose laser power will be delivered to the cavity at a constant fluence rate The laser power required to obtain the desired fluence rate at the wall will be calculated purely based on the abscess size For subjects in Group 2 MB-PDT with patient-specific treatment planning the subjects measured optical properties and their segmented pre-procedure CT images will be integrated with treatment planning software to determine the laser power required to deliver the desired fluence rate to 95 of the abscess wall while limiting the portion of the abscess wall that receives a fluence rate of 400 mWcm2 to less than 5 In both cases illumination will be delivered for 20 minutes resulting in a total delivered fluence of 24 Jcm2 Immediately after laser irradiation the Intralipid solution will be aspirated and the cavity again flushed with sterile saline
Collection of aspirated abscess material for microbiological assessment is standard of care for percutaneous abscess drainage A portion of this standard of care collection will be collected by the study team for additional quantitative evaluation Additionally a post-intervention aspirate sample will be collected for study purposes For subjects in Groups 1 and 2 MB-PDT this sample will consist of the aspirated saline used to flush the abscess cavity after Intralipid aspiration For subjects in Group 3 this sample will consist of the aspirated saline used to flush the cavity following drainage
If successful this research could result in an adjunct treatment for abscess patients that improves long-term abscess resolution and the rate of response to percutaneous drainage This clinical strategy would offer a wide range of potential health benefits to patients with deep tissue abscess Among these advantages are reduced surgical intervention decreased spread of infection shortened course of post-treatment antibiotic therapy and decreased selective pressure for antibiotic resistance Ultimately this would promote early recovery shorten hospital stay and lead to lower overall health care costs for patients undergoing image-guided percutaneous abscess drainage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None