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Dosimetry Based PRRT Versus Standard Dose PRRT With Lu-177-DOTATOC in NEN Patients

Plain-language guide to NCT04917484: phase 2 randomized trial of Octreotide, 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04917484
Phase
phase 2
Status
recruiting participants
Start
2020-02-01
Completion (planned or actual)
2025-12
Participants
100 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Neuroendocrine Neoplasm
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around Octreotide.

A max of 20GBq will be administered at the first treatment and 25GBq at treatment 2-4.

It had two arms (groups): Standard (active comparator) and Dosimetry (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 100 planned participants were the target.

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: 1\. Male or female patients 18 years of age or more. 2\. NEN confirmed by histology. 4\. WHO/ ECOG Performance Status of 0-2. 5\. Life expectancy more than 6 months. 7\. Adequate organ function as defined by:.

The full record lists 13 inclusion and 10 exclusion criteria; among the exclusions: 1\. tumor amenable to surgery and/or radiofrequency ablation; 2\. patients who are unable to stay isolated for 24 hours; 3\. previous prrt.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Octreotide group and the comparison group ran side by side rather than switching.

Being open-label, the Octreotide study did not mask who received what.

It started in 2020-02-01 with completion listed for 2025-12.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Progression free survival (time frame: 12 months after LPLV).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 100 people.

It is still recruiting; 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.