Review of Medical Records of Patients Who Have Been Treated With Lutetium at the Cross Cancer Institute Between January 2010 and April 30, 2014
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01763554|
Recruitment Status : Active, not recruiting
First Posted : January 9, 2013
Last Update Posted : November 20, 2017
|Condition or disease||Intervention/treatment|
|Neuroendocrine Tumors, NET||Drug: Lu-177 DOTA-TATE|
|Study Type :||Observational|
|Estimated Enrollment :||115 participants|
|Official Title:||Review of Medical Records of Patients Who Have Been Treated With Lutetium at the Cross Cancer Institute Between January 2010 and April 30, 2014|
|Actual Study Start Date :||August 2012|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
- Drug: Lu-177 DOTA-TATE
The regimen used for therapy for patients treated under SAP was a standard dose of 5.55 GBq Lu-177 DOTA-TATE every 10-12 weeks for 4 treatments, then every 6 months as maintenance treatment.
- Efficacy data on subjects with neuroendocrine tumours (NET) treated with Lu-177 DOTA-TATE [ Time Frame: Retrospective data January 2010 - April 30, 2014 ]Data (Radioisotope and CT/MRI images, blood assays and Quality of Life Questionnaires, pre and post treatment) will be collected to determine tumor response of subjects with NET after treatment with Lu-177 DOTA-TATE.
- Safety and other relevant information on subjects treated with Lu-177 DOTA-TATE [ Time Frame: Retrospective data January 2010 - April 30, 2014 ]Safety data will include blood counts and chemistry, GFR and adverse events, pre and post treatment. Other data includes patient demographics.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763554
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Principal Investigator:||Alexander McEwan, MB, FRCPC||Alberta Health Services|