Review of Medical Records of Patients Who Have Been Treated With Lutetium at the Cross Cancer Institute Between January 2010 and April 30, 2014

Neuroendocrine Tumors, NET Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01763554
• Other study ID #: REV-LUT-001
• Status: Active, not recruiting
• Start date: August 2012
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• 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.

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	Cross Cancer Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy data on subjects with neuroendocrine tumours (NET) treated with Lu-177 DOTA-TATE	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.	Retrospective data January 2010 - April 30, 2014
Secondary	Safety and other relevant information on subjects treated with Lu-177 DOTA-TATE	Safety data will include blood counts and chemistry, GFR and adverse events, pre and post treatment. Other data includes patient demographics.	Retrospective data January 2010 - April 30, 2014