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Beta- Probe and Surgery in GEP NET: Evaluation of a New Probe
Plain-language guide to NCT04296149: phase 2 interventional trial of Octreotide, 5 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04296149
- Phase
- phase 2
- Status
- completed
- Start
- 2017-02-16
- Completion (planned or actual)
- 2018-12-31
- Participants
- 5 (actual)
- Design
- na, open label (everyone knows who gets what), diagnostic
- Conditions studied
- Neuroendocrine Tumors
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Octreotide.
Radioguided surgery (RGS) with beta- radioisotopes is a novel approach focused on developing a new probe which, detecting electrons and operating with low background, provides a clearer delineation of the margins of lesions with low radiation exposition for surgeons.
To validate this procedure, ex vivo specimens of tumours expressing somatostatin receptors, as small-intestine neuroendocrine (SI-NET), will be tested.
It had 1 arm (groups): Y-90-DOTATOC (experimental).
Patients affected by Small Intestine neuroendocrine tumors.
The registry classes the interventions as drug.
More on the Plan
Small Intestinal neuroendocrine patients, with a positive Ga-68-DOTATOC PET/CT, will receive a small amount of beta- radiopharmaceutical (Y-90-DOTATOC), and then operated, as clinical indicated.
Tissue samples will be tested ex-vivo with a beta-probe prototype.
Who Took Part
The registry lists 5 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: SI NET patients, Ga-68-DOTATOC PET/CT positive, proposed for surgery.
The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: negative pet/ct; pregnancy.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2017-02-16 with completion listed for 2018-12-31.
It ran at 1 site in Italy.
Its stated primary purpose is diagnostic.
What Was Measured
Primary outcome: Evaluation of sensitivity of a beta- probe (time frame: 2 years).
What This Means in Plain Language
Put simply, this is a phase 2 trial of Octreotide in 5 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; 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.