Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-01-11 @ 2:56 PM
Study NCT ID:
NCT03197012
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2017-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yttrium-90 DOTA-TOC Intra-arterial (IA) Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumor
Sponsor:
Thomas Hope
Organization:
Study Overview
Official Title:
Yttrium-90 DOTA-TOC Intra-arterial (IA) Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumor
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2017-01886 | REGISTRY | NCI Clinical Trials Reporting Program (CTRP) | View |