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Trial record 13 of 53 for:    DOTA- | Neuroendocrine Tumors

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 : August 22, 2019
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Tracking Information
First Submitted Date December 19, 2012
First Posted Date January 9, 2013
Last Update Posted Date August 22, 2019
Actual Study Start Date August 2012
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 16, 2017)
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.
Original Primary Outcome Measures
 (submitted: January 7, 2013)
Efficacy data on subjects with neuroendocrine tumours (NET) treated Lu-177 DOTA-TATE [ Time Frame: Retrospective data January 2010 - July 2012 ]
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.
Change History
Current Secondary Outcome Measures
 (submitted: November 16, 2017)
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.
Original Secondary Outcome Measures
 (submitted: January 7, 2013)
Safety and other relevant information on subjects treated with Lu-177 DOTA-TATE [ Time Frame: Retrospective data January 2010 - July 2012 ]
Safety data will include blood counts and chemistry, GFR and adverse events, pre and post treatment. Other data includes patient demographics.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Neuroendocrine Tumors, NET
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: November 16, 2017)
115
Original Estimated Enrollment
 (submitted: January 7, 2013)
69
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01763554
Other Study ID Numbers REV-LUT-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AHS Cancer Control Alberta
Study Sponsor AHS Cancer Control Alberta
Collaborators Cross Cancer Institute
Investigators
Principal Investigator: Donald Morrish, MD, PhD Endocrinology & Oncology, University of Alberta, Cross Cancer Institute
PRS Account AHS Cancer Control Alberta
Verification Date November 2018