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| Name | Class |
|---|---|
| Canadian Neuroendocrine Tumour Society (CNETS) | UNKNOWN |
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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 FDG uptake are suggestive of low grade disease, with an indolent course.
Conversely, low DT uptake and high FDG uptake are suggestive of high-grade/ aggressive disease.
G2/3 GEP NETs may be biologically diverse; clinically relevant cohort for dual-tracer PET imaging.
Our secondary objectives are
To assess intra-individual variability in SSTR expression & glucose metabolism (as seen on DT and FDG PET) across different tumor sites within the same patient.
2) To determine whether a correlation exists between tumor texture features on 68Ga-DT & FDG PET to tumor grade and Ki 67 index.
3) To assess for an association between tumor texture features on 68Ga-DT PET and glucose metabolism; and/or an association between tumor texture features on FDG PET and SSTR expression.
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:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-FDG PETCT scan | Other | 18F-FDG tracer (5 MBq/kg body weight of FDG; up to 550 MBq) will be injected into the intravenous |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F18-FDG | Drug | Evaluate FDG uptake |
|
| Measure | Description | Time Frame |
|---|---|---|
| Discordance in tracer uptake: | Discordance in tracer uptake as assessed by PETNET score distribution: Proportion of patients with PETNET score of P1/P2 (no or low FDG uptake) vs those with P3-P5 (moderate or high FDG uptake). | 2 years |
| Impact to patient management: | Impact of the addition of FDG PET to patient management as assessed by rate of clinical management changed after the addition of 18F-FDG PET/CT to 68Ga-DOTATATE PET/CT. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Intraindividual tumor heterogeneity: | Assessment of tumor heterogeneity by measuring the proportion of patients with variable PET NET score at different tumor sites (intraindividual variability). | 2 years |
| Tumor texture geatures as predictors of tumor grade: |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ur Metser, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | 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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Histologically proven well diff GEP NET, G2-3, Ki 67 ≥3% (or mitotic index ≥2 mitosis/10HPF).
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To determine whether tumor texture features on PET correlate with tumor grade and/or Ki-67 index. |
| 2 years |
| Tumor texture features as predictors of tumor metabolism and somatostatin receptor expression: | To determine whether tumor texture features on 68Ga-DOTATATE PET correlate with glucose metabolism (as measured semiquantitatively with SUV on FDG PET); and/or whether tumor texture features on FDG PET correlate with somatostatin receptor expression (as measured semiquantitatively with SUV on 68Ga-DOTATATE PET). | 2 years |
| D009380 | Neoplasms, Nerve Tissue |