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Same-day Radioembolization for Large HCC

ConditionHepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

In patients who has no sign suggesting high lung shunt fraction (TIPS, hepatic vein invasion, hepatic vein enhancement on arterial phase, dysmorphic intratumoral vessel), planning angiography, MAA scan, and radioembolization are performed in a single day with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and same-day radioembolization is feasible and safe.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5)

hepatocellular carcinoma 5cm or larger

dysmorphic intratumoral vessels 3mm or smaller

Child-Pugh class A

Disqualifiers

hepatic vein invasion on CT/MRI

Marked enhancement of portal vein or hepatic vein on arterial phase of CT/MRII

TIPS

dysmorphic intratumoral vessels > 3mm

Trial population

patients with hepatocellular carcinoma who are scheduled for radioembolization

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • same-day radioembolization

    Procedure/Surgery

    On the day of the procedure, angiography is performed, followed by cone-beam CT of the hepatic artery. After injecting 99mTc-MAA into the hepatic artery, the patient is transferred to the nuclear medicine department for a lung shunt scan and lung SPECT/CT. The lung shunt fraction is determined using the planar images. Using diagnostic CT/MRI and 99mTc-MAA images, the treatment dose is calculated with the multi-compartment MIRD method. The acceptable range for tumor absorbed dose is ≥100 Gy, and the lung dose must be ≤15 Gy. The tumor absorbed dose must be at least 100 Gy and should ideally be within the range of 300 to 600 Gy. There is no upper limit for the tumor absorbed dose.

Treatment groups

138 Participants
are divided into 1 treatment group
Group A: same-day group1 intervention

Trial outcomes

Primary outcomes

1

percentage of execution of same-day radioembolization procedure

Execution means that planning angiography, MAA scan and radioembolization are performed in a single day. The number same-day radioembolization is divided by total enrolled patient number.

Time frame
Day 1

Secondary outcomes

1

Objective response rate

objective response rate

Time frame
up to 1 year
2

local progression-free survival

Time frame
From date of radioembolization until the date of first documented progression of treated tumor or date of death from any cause, whichever came first, assessed up to 60 months
3

Progression-free survival

Time frame
From date of radioembolization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
4

overall survival

Time frame
From date of radioembolization until the date of death from any cause, assessed up to 60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov
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