NCT04804371Active, not recruiting
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 · Last updated 23 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 3 Mar 2021
- Start date
- 4 Mar 2021
- Primary completion date
- 22 Feb 2027
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT04804371
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 4 Mar 2021 to the primary completion date, 22 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with any known hypersensitivity to FDG.
- 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.
Other
- Patients with known lung neuroendocrine tumours or other proven non gastroenteropancreatic histologies are not eligible.
- Has a well differentiated neuroendocrine tumour Grade 1 (WHO 2017).
- Has a poorly differentiated neuroendocrine carcinoma (WHO 2017).
- Any patient who is pregnant.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.