Clinical trial · Interventional
Dual Tracer (68Ga-DOTATATE and 18F-FDG) PET Imaging in G2 & G3 Gastroenteropancreatic Neuroendocrine Tumors
Combined 68Ga-DOTATATE and 18F-FDG PET/CT Imaging in Patients With Well-differentiated, G2-G3, Gastroenteropancreatic (GEP)-Neuroendocrine Tumors (NETs) - A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 1. To determine the distribution of PETNET scores derived from 18F-FDG \& 68Ga-DT PET in patients with G2 \& G3 well diff GEP-NETs. 2. To determine the proportion of patients in whom the addition of 18F-FDG PET data results in a change in planned clinical management. 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| F18-FDG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 18F-FDG PETCT scan
- description
- 18F-FDG tracer (5 MBq/kg body weight of FDG; up to 550 MBq) will be injected into the intravenous
- interventionNames
- Drug: F18-FDG
Primary outcomes (2)
- measure
- Discordance in tracer uptake:
- timeFrame
- 2 years
- description
- 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).
- measure
- Impact to patient management:
- timeFrame
- 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Has provided written informed consent prior to any study-related procedures, 2. Is a male or a female of 18 years of age or older. 3. Patients who already had/scheduled for a 68Ga-DOTATATE PET/CT scan. 4. 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. 5. Has a well differentiated tumour Grade 2-3 (WHO 2017). 6. 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) 7. 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. 8. Willing and able to comply with all study requirements, including timing and/or nature of required assessments. 9. Women of child-bearing age will undergo a urine test to exclude pregnancy prior to PET. Exclusion Criteria: 1. Patients with known lung neuroendocrine tumours or other proven non gastroenteropancreatic histologies are not eligible. 2. Patients with any known hypersensitivity to FDG. 3. Has a well differentiated neuroendocrine tumour Grade 1 (WHO 2017). 4. Has a poorly differentiated neuroendocrine carcinoma (WHO 2017). 5. Mixed neuroendocrine and non-neuroendocrine cancer 6. 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. 7. Any patient who is pregnant.
References
Publications (0)
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