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

NCT01763554 — Active not recruiting, 115 participants, AHS Cancer Control Alberta
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RegistryNCT01763554
StatusActive not recruiting
Study typeObservational
Enrollment115 (Estimated)
SponsorAHS Cancer Control Alberta (Other); collaborators: Cross Cancer Institute
ConditionsNeuroendocrine Tumors, NET
InterventionsLu-177 DOTA-TATE (Drug)
Datesstart 2012-08-01, primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2013-01-09, last updated 2026-11-03
Locations1 site in Canada

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-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.

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+Arms and interventions

  • Lu-177 DOTA-TATE (Drug): 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.

+Outcome measures

Primary outcomes

  • Efficacy data on subjects with neuroendocrine tumours (NET) treated with Lu-177 DOTA-TATE [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.

Secondary outcomes

  • Safety and other relevant information on subjects treated with Lu-177 DOTA-TATE [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.

+Eligibility

Sex: All, ages: 14 Years to 90 Years

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.

+Locations (1)

FacilityCityCountryStatus
Cross Cancer InstituteEdmonton, AlbertaCanada

+Investigators

  • Donald Morrish, MD, PhD, Principal investigator, Endocrinology & Oncology, University of Alberta, Cross Cancer Institute

My Notes