New PET scan shows promise for detecting rare tumors
NCT ID NCT06240741
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new imaging method called [68Ga]Ga-DOTA-TATE PET/CT to see how well it finds neuroendocrine tumors compared to standard scans. It included 71 adults in Japan, both with and without the disease. The goal was to prove the new scan works well for diagnosis in Japan.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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71 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Dec 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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.
Key Inclusion Criteria: 1. Signed informed consent must have been obtained prior to participation in the study 2. Participants must have been adults \>= 18 years of age 3. ECOG performance status 0-2 4. For patient with NENs only: Participants were to be confirmed NENs based on histopathology, imaging and other relevant examination, or with suspected NENs which localization could not have been confirmed by CIM 5. For HVs only: Male or female participant in good health condition as determined by no clinically significant findings from medical history, physical examination, vital signs, lab test and ECG 6. Women of childbearing potential must havehad a negative urine or blood pregnancy test. Key Exclusion Criteria: 1. Inability to complete the needed investigational and conventional imaging due to any reason (severe claustrophobia, inability to lie still for the entire imaging time, etc.) 2. Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation 3. Known allergy, hypersensitivity, or intolerance to \[68Ga\]Ga-DOTA-TATE and \[111In\]In-Pentetreotide 4. Therapeutic use of any somatostatin analogue except for the following washout period * Short-acting analogs of somatostatin can be used up to 24 hours before injection of \[68Ga\]Ga-DOTA-TATE. * Long-acting analogs of somatostatin can be used up to 28 days before injection of \[68Ga\]Ga-DOTA-TATE. 5. Prior administration of a radiopharmaceutical unless 10 or more half-lives have elapsed before injection of \[68Ga\]Ga-DOTA-TATE 6. Use of other investigational drugs within 30 days before screening 7. Participants who were pregnant. 8. Participants who were lactating.
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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
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Novartis Investigative Site
Kashiwa, Chiba, 277 8577, Japan
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Novartis Investigative Site
Sapporo, Hokkaido, 060 8648, Japan
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Novartis Investigative Site
Kanazawa, Ishikawa-ken, 920 8641, Japan
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Novartis Investigative Site
Yokohama, Kanagawa-ku, 236-0004, Japan
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Novartis Investigative Site
Chuo Ku, Tokyo, 1040045, Japan
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Novartis Investigative Site
Fukuoka, 8128582, Japan
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Novartis Investigative Site
Fukuoka, 813-0017, Japan
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Novartis Investigative Site
Kyoto, 6068507, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New imaging trial peers inside tumors to track experimental Drug's path
- Experimental combo aims to boost immune attack on tough lung cancers
- New drug combo targets rare, aggressive cancer in early trial
- New drug aims to shrink Hard-to-Treat lung cancers
- New drug combo aims to shrink Hard-to-Treat neuroendocrine tumors