Status:
ACTIVE_NOT_RECRUITING
Dual Tracer (68Ga-DOTATATE and 18F-FDG) PET Imaging in G2 & G3 Gastroenteropancreatic Neuroendocrine Tumors
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Canadian Neuroendocrine Tumour Society (CNETS)
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The variable clinical outcome of patients with G2 \& G3 well diff GEP-NETs makes the selection of an optimal treatment strategy challenging. Initial data suggests that high DOTATATE uptake and low FD...
Detailed Description
The variable clinical outcome of patients with G2 and G3 well differentiated GEP-NETs makes the selection of an optimal treatment strategy challenging. A subject with 68Ga-DOTATATE uptake on all lesi...
Eligibility Criteria
Inclusion
- Has provided written informed consent prior to any study-related procedures,
- Is a male or a female of 18 years of age or older.
- Patients who already had/scheduled for a 68Ga-DOTATATE PET/CT scan.
- Has a gastro entero-pancreatic neuroendocrine neoplasm confirmed by histological criteria. Patients with unknown primaries clinically thought to be from gastroenteropancreatic source shall be eligible.
- Has a well differentiated tumour Grade 2-3 (WHO 2017).
- Has a tumour with a proliferation index (Ki67 ≥3%) or in samples where the Ki67 antigen cannot be reliably quantified, a mitotic index ≥2 mitosis/10HPF (high power fields)
- Treatment naïve patients and/or patient who have received any number of prior systemic therapy lines for metastatic disease and/or locally advanced inoperable tumor.
- Willing and able to comply with all study requirements, including timing and/or nature of required assessments.
- Women of child-bearing age will undergo a urine test to exclude pregnancy prior to PET.
Exclusion
- Patients with known lung neuroendocrine tumours or other proven non gastroenteropancreatic histologies are not eligible.
- Patients with any known hypersensitivity to FDG.
- Has a well differentiated neuroendocrine tumour Grade 1 (WHO 2017).
- Has a poorly differentiated neuroendocrine carcinoma (WHO 2017).
- Mixed neuroendocrine and non-neuroendocrine cancer
- Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
- Any patient who is pregnant.
Key Trial Info
Start Date :
March 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 22 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04804371
Start Date
March 4 2021
End Date
February 22 2026
Last Update
March 28 2025
Active Locations (1)
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1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9