Dual Tracer (68Ga-DOTATATE and 18F-FDG) PET Imaging in G2 & G3 Gastroenteropancreatic Neuroendocrine Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Neuroendocrine Tumors
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Histologically proven well diff GEP NET, G2-3, Ki 67 ?3% (or mitotic index ?2 mitosis/10HPF).Masking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 lesions without FDG uptake is likely to have low-grade, metabolically inactive disease, leading to an ind...
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 lesions without FDG uptake is likely to have low-grade, metabolically inactive disease, leading to an indolent disease course and may also be a predictive biomarker in subjects being considered for PRRT. Conversely, avidity on 18F-FDG PET/CT and non-avidity on 68Ga-DOTATATE may indicate a high-grade NET, and would predict resistance to PRRT, suggesting that a more "aggressive" approach with systemic chemotherapy might be beneficial. Therefore, the prospective assessment of PETNET score in patients with G2 or G3 GEP NETs, which may be biologically diverse is the most clinically relevant group for dual-tracer PET imaging. Primary Objectives: To determine the distribution of PETNET scores derived from 18F-FDG and 68Ga-DOTATATE PET/CT in patients with G2 and G3 well differentiated GEP-NETs. To determine the proportion of patients in whom the addition of 18F-FDG PET/CT data results in a change in planned clinical management. Secondary Objectives: mTo determine whether there is intra-individual variability in somatostatin receptor expression and glucose metabolism (as seen on DOTATATE PET and FDG PET, respectively) across different tumor sites within the same patient. To determine whether a correlation exists between tumor texture features on 68Ga-DOTATATE PET and FDG PET to tumor grade and Ki67 index. To assess if an association exists between tumor texture features on 68Ga-DOTATATE PET and glucose metabolism; and/or an association between tumor texture features on FDG PET and somatostatin receptor expression.
Tracking Information
- NCT #
- NCT04804371
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ur Metser, MD University Health Network, Toronto
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