Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)

What Was Tested

In this phase 2 trial, researchers set out to test Octreotide.

This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with somatostatin receptor positive tumors.

It had 1 arm (groups): 90Y-DOTA-tyr3-Octreotide (experimental).

The registry classes the interventions as diagnostic test, drug and radiation.

More on the Plan

The somatostatin receptor targeting of the therapeutic will be checked with 68Ga-DOTATOC PET-CT imaging prior to therapy.

Treatment consists of 3 cycles, 6-8 weeks apart.

The goals of this project are to 1.

Establish 68Ga-DOTA-tyr3-Octreotide (68Ga-DOTATOC) or 68Ga-DOTATATE PET/CT as an accurate technique for diagnosis, staging, treatment targeting, and monitoring response to 90Y-DOTATOC therapy.

Who Took Part

Enrollment: 39 actual participants took part.

It was open to people of any sex aged from 6 months up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participation in Iowa Neuroendocrine Tumor Registry. Life expectancy \> 2 months at the time of study drug administration. Archival tissue from a previous biopsy will be required. Age ≥ 6 months-90 years at the time of study drug administration. Completion of Norfolk Quality of Life Questionnaire.

The full record lists 18 inclusion and 13 exclusion criteria; among the exclusions: pregnant women are excluded from this study because 90y-dotatoc is a class c agent with potential teratogenic or abortifacient effects; surgery within 4 weeks of study drug administration; prior prrt with 90y-dotatoc (tate) or 177lu-dotatoc (tate) or 131i-mibg therapy for this malignancy.

How the Study Was Run

Design: 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 2017-09-29 with completion listed for 2020-05-27.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Frequency of Tumor Response at 9 Months After Last Treatment (time frame: Baseline through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months). Percentage of Patients With Grade 4 or Higher Renal Adverse Event. Percentage of Patients With Grade 4 or Higher Irreversible Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 39 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Octreotide compound page, all human trials.