Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434909
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-17
Brief Title:
CYTALUXfor the Intraoperative Imaging of Prostate Cancer
Sponsor:
Clinton Bahler
Organization:
Indiana University
Study Overview
Official Title:
An Investigator Sponsored Study to Investigate the Safety and Efficacy of CYTALUX PAFOLACIANINE INJECTION for the Intraoperative Imaging of Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This study is being done to compare how much using Cytalux pafolacianine with NIR Near InfraRed fluorescent imaging improves the detection of malignant growing in an uncontrolled way tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer
The US Food and Drug Administration FDA has approved the targeted imaging agent pafolacianine Cytalux for use in ovarian cancer 2021 and lung cancer surgery 2022
The US Food and Drug Administration FDA has approved the targeted imaging agent pafolacianine Cytalux for use in ovarian cancer 2021 and lung cancer surgery 2022
Detailed Description:
This is an open label trial in up to 15 subjects with biopsy confirmed prostate cancer PCa who have been scheduled to undergo a laparoscopic radical prostatectomy with or without robotic assistance with pelvic lymph node dissection This is a non-intervention trial to assess the accuracy of an imaging agent folate targeted fluorescent dye pafolacianine during a standard of care radical prostatectomy
Qualifying subjects will be Grade Group 3 to 5 cT3 with either suspected extraprostatic disease EPD extracapsular extension ECE andor seminal vesicle infiltration SVI or suspected lymph node metastasis clinical stage cN1 or by magnetic resonance imaging mriN or by Prostate Specific Membrane Antigen positron emission tomography PSMA PET
Whether using an anterior or a posterior approach the tissues planned for removal will be visualized first under normal light and their locations marked on a provided template All additional suspicious tissue or nodes will be similarly marked whether removed or not Prior to removal the field must be illuminated with Near Infrared light NIR and fluorescent tissues must be marked on the template This may proceed in an iterative fashion switching from first normal light to NIR as the surgical field expands
NIR imaging must be conducted in the timeframe of one hour to twenty-four hours following IV infusion of pafolacianine Lymphatics to be examined are at a minimum the external iliac internal iliac and obturator fossa and common iliac Fluorescence positive nodules and nodes will be removed at the surgeons discretion and sent as labeled specimen number tissue location specimens to pathology without designation of florescence Ink dots should ideally be applied to the spot suspected of being cancerous
Qualifying subjects will be Grade Group 3 to 5 cT3 with either suspected extraprostatic disease EPD extracapsular extension ECE andor seminal vesicle infiltration SVI or suspected lymph node metastasis clinical stage cN1 or by magnetic resonance imaging mriN or by Prostate Specific Membrane Antigen positron emission tomography PSMA PET
Whether using an anterior or a posterior approach the tissues planned for removal will be visualized first under normal light and their locations marked on a provided template All additional suspicious tissue or nodes will be similarly marked whether removed or not Prior to removal the field must be illuminated with Near Infrared light NIR and fluorescent tissues must be marked on the template This may proceed in an iterative fashion switching from first normal light to NIR as the surgical field expands
NIR imaging must be conducted in the timeframe of one hour to twenty-four hours following IV infusion of pafolacianine Lymphatics to be examined are at a minimum the external iliac internal iliac and obturator fossa and common iliac Fluorescence positive nodules and nodes will be removed at the surgeons discretion and sent as labeled specimen number tissue location specimens to pathology without designation of florescence Ink dots should ideally be applied to the spot suspected of being cancerous
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?:
True
Is an FDA AA801 Violation?:
None