CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
SIR-Spheres microspheresdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04172714
NCT04172714N/ACompleted

Theragnostic Low Dose Y90 Microspheres for Personalized Y90 Radioembolization Dosimetry Planning

Emory University·interventional·Posted Nov 21, 2019·Updated Dec 6, 2022

In Brief

A clinical study evaluating SIR-Spheres microspheres for HCC and 2 related conditions. Completed, enrolled 30 participants across 3 sites.

Detailed Summary

The study proposes low-dose Y90 microspheres for therapy planning of HCC, as an alternative to Technetium (99mTc) albumin aggregated (MAA), to be a bioidentical therapeutic Y90 surrogate marker to better predict and thus achieve optimal therapeutic dosing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 21, 2019
Enrollment StartDec 16, 2019
Primary CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.6 years ago

Interventions

SIR-Spheres microspheresdevice

SIR-Spheres® Y-90 resin microspheres consist of biocompatible polymer resin microspheres of a median diameter of 32.5 microns (range between 20 and 60 microns) loaded with yttrium-90 (beta radiation penetrating an average of 2.5 mm in tissue to destroy tumor cells). The resin microspheres are small enough to become lodged in the arterioles within the growing rim of the tumor but are too large to pass through the capillaries and into the venous system. Since yttrium-90 has a half-life of 64.1 hours, most of the radiation (94%) is delivered to the tumor over 11 days.