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Validation of 99mTc- EDDA - HYNIC -TOC Kits for Diagnosis of Neuroendocrine Tumors
Plain-language guide to NCT02691078: phase 2 interventional trial of Octreotide, 15 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02691078
- Phase
- phase 2
- Status
- completed
- Start
- 2016-07
- Completion (planned or actual)
- 2018-01
- Participants
- 15 (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
In this phase 2 trial, researchers set out to test Octreotide.
Evaluation of the properties of the image capture test using 99m Tc - HYNIC -TOC EDDA (octreotide labeled with 99mTc) for the diagnosis of neuroendocrine tumors compared to the 111In - DTPA-octreotide.
It had 1 arm (groups): Adult patients with neuroendocrine tumors (experimental).
The registry classes the interventions as other.
Who Took Part
15 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: Patients with histological diagnosis of neuroendocrine tumors. Patients with indication for the staging exam with 11In. Patients diagnosed in any tumor stage. Patients with \> 18 years. Male and female patients.
The full record lists 6 inclusion and 2 exclusion criteria; among the exclusions: pregnant women; patients with previous tumor resection of the primary tumor without metastatic disease.
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 2016-07 with completion listed for 2018-01.
It ran at 1 site in Brazil.
Its stated primary purpose is diagnostic.
What Was Measured
The main thing measured (primary outcome): Analysis of the images captured with 99m Tc - HYNIC -TOC EDDA ( octreotide labeled with 99mTc ) and 111In - DTPA-octreotide for the diagnosis of neurocrine tumors (time frame: Up to 30 days).
It also tracked 2 secondary outcomes, for example Visualization of the ocurrence of the neuroendocrine tumor lesions with both radiopharmaceutical agents and Number of neuroendocrine tumor lesions visualized with both radiopharmaceutical agents.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Octreotide in 15 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.