Intraluminal Bile duct high dose rate brachytherapy for malignant biliary tract obstruction
Clinicaltrials.gov ID
Status
Recruiting
Study Type
Sponsor
Start Date
6 février 2025
Anticipated End Date
Study Contact
Name: Dr. Amandeep Taggar
Email: aman.taggar@sunnybrook.ca
About the Study
Brachytherapy is a cancer treatment that involves placing a radioactive source directly into cancerous tissue. It delivers high doses of radiation to tumors while minimizing damage to surrounding tissues. This technique is commonly used for prostate, breast, gynecological, and now bile duct cancers. During the procedure, radioactive seeds are precisely placed near the tumor, guided by magnetic resonance imaging (MRI). This ensures the maximum radiation dose reaches the tumor while reducing impact on nearby organs.
The primary objective of this study is prolonging stent patency and improving Quality of Life. The secondary objective is to improve Overall Survival.
Conditions
Patients with malignant biliary tract obstruction secondary to cholangiocarcinoma or pancreatic head tumor, who are not deemed surgical candidates.
· Hilar, mid and distal CBD tumors (primary or metastatic)
· Depth of invasion ≤2cm from the duct
· ECOG ≤3
· Life expectancy >3 months
· Bilirubin normalized or trending downwards
Inclusion/Exclusion Criteria?
Primary, Secondary, Other Outcome Measures??
Locations in Canada
Sunnybrook Hospital, Toronto, Ontario
About the Study
Brachytherapy is a cancer treatment that involves placing a radioactive source directly into cancerous tissue. It delivers high doses of radiation to tumors while minimizing damage to surrounding tissues. This technique is commonly used for prostate, breast, gynecological, and now bile duct cancers. During the procedure, radioactive seeds are precisely placed near the tumor, guided by magnetic resonance imaging (MRI). This ensures the maximum radiation dose reaches the tumor while reducing impact on nearby organs.
The primary objective of this study is prolonging stent patency and improving Quality of Life. The secondary objective is to improve Overall Survival.
Conditions
Patients with malignant biliary tract obstruction secondary to cholangiocarcinoma or pancreatic head tumor, who are not deemed surgical candidates.
· Hilar, mid and distal CBD tumors (primary or metastatic)
· Depth of invasion ≤2cm from the duct
· ECOG ≤3
· Life expectancy >3 months
· Bilirubin normalized or trending downwards
Interventions
Radioactive "seeds" placed in close proximity to the tumour, guided by MRI
Locations in Canada
Sunnybrook Hospital, Toronto, Ontario