Can a sharper PET tracer light up hidden neuroendocrine tumors?
NCT ID NCT03145857
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This trial tests an injected tracer called Gallium-68 HA-DOTATATE, which binds to somatostatin receptors found on most neuroendocrine tumors. Researchers want to see if a PET/CT or PET/MRI scan using this tracer is safe and accurately detects these tumors compared with standard CT scans. The study enrolls people with known or suspected somatostatin-positive tumors, such as neuroendocrine tumors. Participants receive one injection before imaging, and some also have blood tests and vital sign checks to monitor safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gallium-68 HA-DOTATATE, a radioactive tracer injected before a PET/CT or PET/MRI scan to light up somatostatin receptors on tumors
- What this could lead to
- If it works, this scan could become a more accurate way to detect and map neuroendocrine tumors, helping doctors plan treatment with clearer images.
- What could go wrong
- This is an early-phase study, so the tracer's safety and accuracy are still unproven. It may not perform better than existing scans, and there is a small risk of side effects from the injection or radiation exposure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
634 people
The number who actually took part.
- Started
-
Mar 2020
- Finished
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Aug 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
14 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Known or suspected somatostatin receptor positive tumour including, but not limited to, GNET, PNET, pulmonary NET, PRUNK NET, pheochromocytoma, paraganglioma, medullary thyroid cancer, and medulloblastoma. A standard CT obtained within 6 months of enrolment is required. A standard MRI obtained within 6 months of enrolment is optional. Additional supporting evidence obtained within 12 months of enrolment may include: other standard imaging (In-111 octreotide (Octreoscan), \[18\]F-FDG PET, or \[18\]F-FDOPA PET); histopathology from surgery or biopsy; elevated biochemical markers (including Chromogranin A, 5-HIAA, insulin, vasoactive intestinal peptide (VIP), glucagon, gastrin, metanephrines, and/or others, as clinically indicated); and/or persistent carcinoid-like symptomology highly suspicious for the presence of NET even in absence of pathologic imaging findings by anatomic criteria; 2. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 3 within 2 weeks of enrolment; 3. At least 14 years of age; 4. Able and willing to follow instructions and comply with the protocol; 5. Ability to provide written informed consent prior to participation in the study. Exclusion Criteria: 1. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.); 2. Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.); 3. Any additional medical condition, serious inter-current illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance or interpretation; 4. Weight exceeding the PET/CT or PET/MR scanner limit; 5. Pregnancy; 6. Allergic reaction to DOTATATE or somatostatin analogues.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
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