Dosimetry Guided PRRT With 90Y-DOTATOC

Status Withdrawn

Clinical Trial Summary

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

Clinical Trial Description

This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with somatostatin receptor positive tumors. 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. Cycle 1 dose is fixed with Cycles 2 and 3 doses to be determined by dosimetry-based calculation of renal doses from previous cycles not to exceed 23 Gy for the total renal dose.

The goals of the project are to

1. Demonstrate safety and efficacy of renal uptake dosimetry-guided peptide receptor radiotherapy (PRRT) using 90Y-DOTA-tyr3-Octreotide (90Y-DOTATOC) in patients with neuroendocrine and other somatostatin receptor expressing tumors.

2. Monitor all adverse events associated with peptide receptor radiotherapy using 90Y-DOTATOC.

3. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03013387
Study type	Interventional
Source	University of Iowa
Contact
Status	Withdrawn
Phase	Phase 2
Start date	January 2017
Completion date	October 2019

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