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Dosimetry Guided PRRT With 90Y-DOTATOC
Plain-language guide to NCT03013387: phase 2 interventional trial of Octreotide. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03013387
- Phase
- phase 2
- Status
- withdrawn
- Start
- 2017-01
- Completion (planned or actual)
- 2018-10
- Participants
- n/a (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Neuroendrocrine Tumors; Meningioma; Neuroblastoma; Medulloblastoma
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around 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): PRRT with 90Y--DOTA-tyr3-Octreotide (experimental).
The registry classes the interventions as drug, procedure 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 the project are to 1.
Establish 68Ga-DOTA-tyr3-Octreotide (68Ga-DOTATOC) PET/CT as an accurate technique for diagnosis, staging, treatment targeting, and monitoring response to 90Y-DOTATOC therapy.
Who 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 22 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.
Being open-label, the Octreotide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2017-01 with completion listed for 2018-10.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Renal, hematologic, and clinical toxicities.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Octreotide in people.
It was withdrawn before enrolling anyone; 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.