CClinicalTrials.gg
Active, not recruitingNCT01763554Updated Jan 30, 2024

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

An observational study in Neuroendocrine Tumors, NET, sponsored by AHS Cancer Control Alberta. Active, not recruiting at 1 site in Canada. Open to participants aged 14 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by AHS Cancer Control Alberta · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
115
Ages
14 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Neuroendocrine Tumors, NET

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Keywords

  • Lu-177
  • Lutetium-177
  • DOTA-TATE
  • Neuroendocrine tumors
  • radiopharmaceutical
03

In context

Neuroendocrine Tumors

676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.

This study's planned enrollment of 115 is close to the median of 115 across 176 observational studies indexed under Neuroendocrine Tumors.

Browse Neuroendocrine Tumors studies →

Lead sponsor

AHS Cancer Control Alberta is the lead sponsor of 182 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 90 Years
Sexes eligible
All
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.

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.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
115 participants (estimated)
Patient registry
No

Interventions

  • DrugLu-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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Retrospective data January 2010 - April 30, 2014

Secondary outcomes

  1. 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.

    Time frame: Retrospective data January 2010 - April 30, 2014

07

Study locations

1 site
  • Cross Cancer Institute
    Edmonton, Alberta T6G 1Z2, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01763554
Lead sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute
Responsible party
Sponsor
First posted
Jan 9, 2013
Start date
Aug 2012
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jan 30, 2024

Study contacts

Donald Morrish, MD, PhD
principal investigator · Endocrinology & Oncology, University of Alberta, Cross Cancer Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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