Ignite Creation Date:
2024-05-05 @ 10:52 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01209013
Status:
WITHDRAWN
Last Update Posted:
2012-05-08
First Post:
2010-09-17
Brief Title:
Safety of Photodynamic Therapy PDT in the Ablation of High-grade Dysplasia HGD in Barretts Esophagus BE
Sponsor:
Pinnacle Biologics Inc
Organization:
Pinnacle Biologics Inc
Study Overview
Official Title:
Multicenter Prospective Open-label Single-arm Phase IIIbIV Clinical Study on the Safety of Photodynamic Therapy With Porfimer Sodium for Injection for the Ablation of High-grade Dysplasia in Barretts Esophagus
Status:
WITHDRAWN
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor cancelled the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Oedisse
Brief Summary:
Photodynamic therapy PDT uses a combination of a drug porfimer sodium and a light from a non heated laser The activation of the drug is done by lighting of abnormal areas using a fiber optic device The fiber optic device is a very fine fiber like a fishing line that permits transmission of light The fiber optic device is inserted into a diffusing balloon device to ensure the good positioning of the fiber optic within the esophagus food pipe It is thought that the size and the flexibility of a new diffusing balloon device could improve the safety profile of the photodynamic treatment by reducing the risk of narrowing or closure of the food pipe esophageal stenosis sometimes occurring after treatment
This research study will evaluate the safety and effectiveness of PDT with porfimer sodium using a new diffusing balloon device for light application in the removal of high-grade dysplasia HGD precancerous change in the food pipe tissue in Barretts esophagus BE This study will provide advanced knowledge about phototoxicity reaction similar to sunburn and esophageal stenosis main risks with this therapy It will involve 75 patients with HGD in BE across North America and Europe and will last between 13 and 16 weeks In addition concentrations of porfimer sodium in the esophageal tissue will be analyzed in a subgroup of patients
This research study will evaluate the safety and effectiveness of PDT with porfimer sodium using a new diffusing balloon device for light application in the removal of high-grade dysplasia HGD precancerous change in the food pipe tissue in Barretts esophagus BE This study will provide advanced knowledge about phototoxicity reaction similar to sunburn and esophageal stenosis main risks with this therapy It will involve 75 patients with HGD in BE across North America and Europe and will last between 13 and 16 weeks In addition concentrations of porfimer sodium in the esophageal tissue will be analyzed in a subgroup of patients
Detailed Description:
Patients with biopsy-confirmed HGD in BE will be evaluated to confirm eligibility Prior to enrollment all inclusion and exclusion criteria will be verified Medical procedures including demographic information medicalsurgical history concurrent medical conditions physical exam including vital signs body weight height and skin color degree of difficulty in swallowing electrocardiogram chest X-ray clinical laboratory testing concomitant medication intake and other therapy uses will be collected
All patients will receive one course of PDT consisting of an intravenous injection of 20 mgkg of porfimer sodium over 3-5 minutes followed by one or two endoscopic laser light applications The first laser light application will be performed within 40-50 hours using a new diffusing balloon catheter The second laser light application without a diffusing balloon catheter will be performed within 96-120 hours on those areas showing an insufficient response to the first application Follow-ups Weeks 4 and 13 will include some or all of the following procedures physical exam vital signs evaluation body weight endoscopy skin degree of difficulty in swallowing and esophageal stenosis assessment and clinical laboratory check All patients will be asked general open questions about any occurrence of adverse events change in concurrent medical conditions use of adjunctive therapyprocedure and intake of concomitant medication All patients will undergo rigorous systematic endoscopic biopsy surveillance at Week 13 final visit
Tissue concentration of oligomers component of porfimer sodium in normal and abnormal esophageal tissues will be determined in a subgroup of 12 patients These patients will provide esophageal tissue samples before the porfimer sodium injection and on four separate occasions after the injection 22-26 hour- 40-50 hour- 96-120 hour-intervals and 13 weeks
All patients will be followed for three months
All patients will receive one course of PDT consisting of an intravenous injection of 20 mgkg of porfimer sodium over 3-5 minutes followed by one or two endoscopic laser light applications The first laser light application will be performed within 40-50 hours using a new diffusing balloon catheter The second laser light application without a diffusing balloon catheter will be performed within 96-120 hours on those areas showing an insufficient response to the first application Follow-ups Weeks 4 and 13 will include some or all of the following procedures physical exam vital signs evaluation body weight endoscopy skin degree of difficulty in swallowing and esophageal stenosis assessment and clinical laboratory check All patients will be asked general open questions about any occurrence of adverse events change in concurrent medical conditions use of adjunctive therapyprocedure and intake of concomitant medication All patients will undergo rigorous systematic endoscopic biopsy surveillance at Week 13 final visit
Tissue concentration of oligomers component of porfimer sodium in normal and abnormal esophageal tissues will be determined in a subgroup of 12 patients These patients will provide esophageal tissue samples before the porfimer sodium injection and on four separate occasions after the injection 22-26 hour- 40-50 hour- 96-120 hour-intervals and 13 weeks
All patients will be followed for three months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None