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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01763554

Enrollment

115

Registered

2013-01-09

Start date

2012-08-31

Completion date

2025-12-31

Last updated

2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Tumors, NET

Keywords

Lu-177, Lutetium-177, DOTA-TATE, Neuroendocrine tumors, radiopharmaceutical

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.

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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to 90 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026