- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01763554
Review of Medical Records of Patients Who Have Been Treated With Lutetium at the Cross Cancer Institute Between January 2010 and April 30, 2014
January 29, 2024 updated by: AHS Cancer Control Alberta
Retrospective review of the medical files of 115 patients with neuroendocrine tumours who were treated with Lutetium-177 DOTA-TATE under Health Canada's Special Access Programme (SAP) at the Cross Cancer Institute between January 2010 and April 30, 2014.
Efficacy, safety, and other relevant data will be collected to support a separate clinical trial application.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
115
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Limited to those subjects with neuroendocrine tumors who received Lu-177 DOTA-TATE treatment under SAP at the Cross Cancer Institute between January 2010 and April 30, 2014.
Description
Subjects with neuroendocrine tumours who received Lu-177 DOTA-TATE treatment under SAP at the Cross Cancer Institute between January 2010 and April 30, 2014.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy data on subjects with neuroendocrine tumours (NET) treated with Lu-177 DOTA-TATE
Time Frame: Retrospective data January 2010 - April 30, 2014
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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.
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Retrospective data January 2010 - April 30, 2014
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Retrospective data January 2010 - April 30, 2014
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Donald Morrish, MD, PhD, Endocrinology & Oncology, University of Alberta, Cross Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2012
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
December 19, 2012
First Submitted That Met QC Criteria
January 7, 2013
First Posted (Estimated)
January 9, 2013
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REV-LUT-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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H. Lee Moffitt Cancer Center and Research InstitutePharmacyclics LLC.CompletedCarcinoid Tumors | Pancreatic NETUnited States
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IRCCS San RaffaeleActive, not recruitingNeuroendocrine Tumors | GEP-NETItaly
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Peking Union Medical College HospitalNational Institute for Biomedical Imaging and Bioengineering (NIBIB)Unknown
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Lawson Health Research InstituteActive, not recruiting
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Peking Union Medical College HospitalRecruitingNeuroendocrine TumorsChina
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Lund University HospitalCompletedNeuroendocrine Tumors | Liver MetastasesSweden
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