Actively Recruiting
A Trial to Assess the Safety and Effectiveness of Lutetium-177 Octreotate Therapy in Neuroendocrine Tumours
Led by AHS Cancer Control Alberta · Updated on 2025-08-08
500
Participants Needed
1
Research Sites
1491 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neuroendocrine tumours (NETs) are rare, slow growing, and diagnosis is often delayed with advanced metastases at presentation. In select patient populations, radioisotope therapy with Lutetium-177 (Lu-DOTA-TATE) has been shown to be a safe and effective palliative therapy, and has been widely used by research groups in Europe. A brand of Lu-DOTA-TATE (Lutathera(R)) is approved for the treatment of gastroenteropancreatic NETs in Europe, the U.S., and more recently in Canada. While Lutathera(R) is approved in Canada, it is not publicly funded in Alberta. Lu-DOTA-TATE has been used at the Cross Cancer Institute to treat more than 300 patients with NETs since August, 2010. Our Lu-DOTA-TATE treatment was initially given under Health Canada's Special Access Programme (SAP), with each individual treatment requiring separate approval. In 2014, Health Canada requested we conduct a clinical trial with Lu-DOTA-TATE instead. The purpose of this study is to: 1) assess the efficacy of Lu-DOTA-TATE treatment in patients with somatostatin receptor positive tumours; 2) assess the safety of Lu-DOTA-TATE; 3) assess the effect of Lu-DOTA-TATE on Quality of Life and survival.
CONDITIONS
Official Title
A Trial to Assess the Safety and Effectiveness of Lutetium-177 Octreotate Therapy in Neuroendocrine Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 14 to 90 years
- At least one tumor site measurable by CT or MRI with somatostatin receptor positive uptake confirmed by imaging
- Histologically confirmed neuroendocrine tumor diagnosis
- Progressive disease or refractory symptoms despite somatostatin receptor analogue treatment
- Whole-body 18F-FDG PET/CT imaging within 26 weeks of enrollment
- Life expectancy greater than 12 weeks
- Kidney function with serum creatinine ≤ 150 µmol/L and GFR ≥ 50 mL/min within 2 weeks of enrollment
- Blood counts with hemoglobin ≥ 90 g/L, WBC ≥ 2 x 10^9/L, platelets ≥ 100 x 10^9/L within 2 weeks of enrollment
- Liver function tests within 3 times normal limits and serum albumin ≥ 23 g/L within 2 weeks of enrollment
- ECOG Performance Scale Score ≤ 2 within 2 weeks of enrollment
- Provide written informed consent prior to enrollment
- For maintenance therapy group: previously received Lu-DOTA-TATE under the Special Access Programme
You will not qualify if you...
- Prior Lu-DOTA-TATE therapy for primary therapy group
- Potential for curative surgery; local surgery allowed if target lesion unaffected
- Major surgery within 12 weeks before enrollment; minor surgery permitted
- Liver embolization within 4 weeks before enrollment
- Radioisotope therapy within 12 weeks before enrollment
- Certain systemic therapies within 6 to 8 weeks before enrollment
- Changes in long-acting somatostatin analogues within 12 weeks unless needed for symptoms
- Localized external beam radiation to target lesions
- Untreated or unstable brain metastases
- Uncontrolled diabetes mellitus
- Significant uncontrolled medical, psychiatric, or surgical conditions
- Pregnancy or breastfeeding
- Prior radiation therapy to over 25% of bone marrow
- Known allergy to somatostatin analogues or study medication components
- If other treatments are considered more suitable by the investigator
- For maintenance group: uncontrolled significant medical or psychiatric conditions, pregnancy, breastfeeding, or known allergy to study medication
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
Research Team
N
NET Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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