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| Name | Class |
|---|---|
| Cross Cancer Institute | OTHER |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Donald Morrish, MD, PhD | Endocrinology & Oncology, University of Alberta, Cross Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D009380 | Neoplasms, Nerve Tissue |