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 | Unknown

• 1 other identifier: REV-LUT-001
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors, NET

Keywords

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

Outcome Measures

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.

  Retrospective data January 2010 - April 30, 2014

Secondary Outcomes (1)

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

  Retrospective data January 2010 - April 30, 2014

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.

Eligibility Criteria

• Age: 14 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Cross Cancer Institute: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Donald Morrish, MD, PhD

  Endocrinology & Oncology, University of Alberta, Cross Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: January 9, 2013
• Study Start: August 1, 2012
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

CA (1)