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A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms
Plain-language guide to NCT03511768: phase 1, phase 2 interventional trial of Octreotide, 65 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03511768
- Phase
- phase 1, phase 2
- Status
- status unknown
- Start
- 2018-01-02
- Completion (planned or actual)
- 2019-12-30
- Participants
- 65 (estimated)
- Design
- na, open label (everyone knows who gets what), diagnostic
- Conditions studied
- Neuroendocrine Neoplasm
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1, phase 2) is built around Octreotide.
The aim of this study is to investigate the clinical value of \[18F\]aluminum fluoride-1,4,7-triazacyclononane-1,4,7-triacetic acid-octreotide（18F-AlF-NOTA-octreotide ） positron emission tomography / computed tomography (PET/CT) in patients with neuroendocrine neoplasms (NENs).
It had 1 arm (groups): 18F-AlF-NOTA-octreotide PET/CT (experimental).
One injection of the radioligand 18F-AlF-NOTA-octreotide.
The registry classes the interventions as device and drug.
More on the Plan
18F-AlF-NOTA-octreotide is a radioligand targeting the somatostatin receptor, which is widely expressed on the cell surface of NENs.
The radioligand can be used for the diagnosis and stage of the NENs.
A total of 5 volunteers and 60 NEN patients will be subjected to a 18F-AlF-NOTA-octreotide PET/CT scan.
The uptake of 18F-AlF-NOTA-octreotide in organs and tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean).
Who Took Part
65 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Histologically and/or clinically confirmed and/or suspicious of NEN. Signed informed consent.
The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: claustrophobia (unable to accept pet/ct scanning); pregnant or breast-feeding.
How the Study Was Run
Design: single-group and open-label.
Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2018-01-02 with completion listed for 2019-12-30.
It ran at 1 site in China.
Its stated primary purpose is diagnostic.
What Was Measured
The main thing measured (primary outcome): 18F-AlF-NOTA-octreotide PET/CT imaging of patients with Neuroendocrine Neoplasms (time frame: 12 months).
It also tracked 1 secondary outcome, for example 18F-AlF-NOTA-octreotide PET/CT prognostic factor for overall and disease specific survival.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2 trial of Octreotide in 65 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Octreotide compound page, all human trials.
Our Notes on the Compound
Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.