Neuroendocrine Tumor Clinical Trial
Official title:
Yttrium-90 DOTA-TOC Intra-arterial (IA) Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumor
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.
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.
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