Ignite Creation Date:
2024-05-05 @ 10:51 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01203163
Status:
WITHDRAWN
Last Update Posted:
2012-05-09
First Post:
2010-09-15
Brief Title:
Case Analysis on Real Life Incidence of Photodynamic Therapy PDT Safety Outcomes
Sponsor:
Pinnacle Biologics Inc
Organization:
Pinnacle Biologics Inc
Study Overview
Official Title:
Case Analysis on Real Life Incidence of PDT Safety Outcomes Multicentre Observational Post-marketing Safety Surveillance Registry of Patients Exposed to Photodynamic Therapy With Porfimer Sodium The CALIPSO Registry
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WITHDRAWN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:
CALIPSO
Brief Summary:
Three main adverse reactions namely photosensitivity reaction that is similar to sunburn oesophageal stenosis narrowing or closure of the food pipe perforation of the treated area a tear or puncture of the tissue have been identified in research studies evaluating photodynamic therapy PDT with porfimer sodium Because of the low incidence of the disease or the variation in the occurrence of these adverse reactions among different indications it is difficult to determine the occurrence and frequency of these safety issues in routine clinical practice
This post-marketing safety surveillance registry is set-up to evaluate the safety of PDT using porfimer sodium A registry allows the collection of data to evaluate real-world results in the practice of medicine The registry will monitor the patients health and any events with a main focus on photosensitivity oesophageal stenosis and perforation of the treated area This registry will involve 500 patients across 20 to 36 hospitals in the US and Europe scheduled to receive an injection of porfimer sodium with PDT for the treatment of lung cancer esophageal food pipe cancer or high-grade dysplasia HGD precancerous change in the food pipe tissue in Barretts esophagus
This post-marketing safety surveillance registry is set-up to evaluate the safety of PDT using porfimer sodium A registry allows the collection of data to evaluate real-world results in the practice of medicine The registry will monitor the patients health and any events with a main focus on photosensitivity oesophageal stenosis and perforation of the treated area This registry will involve 500 patients across 20 to 36 hospitals in the US and Europe scheduled to receive an injection of porfimer sodium with PDT for the treatment of lung cancer esophageal food pipe cancer or high-grade dysplasia HGD precancerous change in the food pipe tissue in Barretts esophagus
Detailed Description:
Patients will be enrolled in the registry upon injection of the porfimer sodium During normal medical examination criteria for entry onto the registry will be verified to confirm eligibility and medical procedures including demographic information disease history medical history physical exam and clinical laboratory testing performed under normal practice will be collected Patients will receive PDT as per current practice and will be repeated as per the physicians judgment All patients will be assessed as per current practice that is usually at least three times after a PDT session Additional visits will be sought for those patients who are presenting photosensitivity reaction esophageal stenosis perforation at the site of laser light application or any unresolved serious adverse reactions at the third visit after treatment All patients will be requested by their physician to complete a two-part Daily Diary to record adverse reactions using a check-list form and a general section for reporting any adverse events and intake of concomitant medications at the time of the adverse event
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