NCT03197012

Yttrium-90 DOTA-TOC Intra-arterial (IA) Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumor

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Thomas Hope · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, pilot, single center, open-label study in patients with metastatic neuroendocrine tumor. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive a one-time administration of 90Y-DOTA-TOC via the hepatic artery. Participants in the correlative sub-study will receive 68Ga-DOTA-TOC concurrent with the 90Y-DOTA-TOC dose, and undergo additional imaging and assessment.

Detailed description

Prior to the procedure, the patient will be instructed to fast overnight. Upon arrival to the hospital intravenous (IV) access will be placed, and Additionally, a scopolamine patch may be placed the night prior to treatment. Additionally a Foley catheter will be placed. Starting 30 minutes prior to the administration of 90Y-DOTA-TOC, an amino acid solution will be administered via IV. An angiographic catheter will be directed under fluoroscopic guidance to the appropriate location in the hepatic artery. The 90Y-DOTA-TOC dose will be administered over thirty minutes via the hepatic arterial catheter in an outpatient setting. Ten patients also enrolled in the correlative sub-study will receive 68Ga-DOTA-TOC concurrent with the therapeutic dose and 90 minutes after treatment, these patients will be imaged 90 minutes after treatment using a Positron Emission Tomography (PET) combined with Computerized tomography (CT) (PET/CT) and the following day using Positron Emission Tomography (PET) combined with magnetic resonance imaging (MRI) (PET/MR). All study participants will be followed up on protocol for six months for evaluation of toxicity and response to treatment.

Conditions

• Neuroendocrine Tumor

Interventions

Type	Name	Description
DRUG	90Y-DOTA-TOC	Starting 30 minutes prior to the administration of 90Y-DOTA-TOC, amino acid solution will be administered via IV, and will continue through the PRRT procedure. An angiographic catheter will be inserted under fluoroscopic guidance to the appropriate location in the hepatic artery. 90Y-DOTA-TOC will be administered via the hepatic arterial catheter.
DRUG	68Ga-DOTA-TOC	In the sub-study, 10 patients will receive 68Ga-DOTA-TOC concurrent with the 90Y-DOTA-TOC dose and 90 minutes after treatment, these patients will be imaged using a PET/CT. The following day, patients enrolled in the sub-study will undergo a PET/MRI.

Timeline

• Start date: 2017-07-01
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2017-06-23
• Last updated: 2020-07-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study