SEGWAY(Short-term Embolization Using Gelatin Particles for floW modulAtion During Y90 Radioembolization)

Nextbiomedical

Status: Enrolling

Conditions: Liver Cancer (Primary and Metastatic)

Treatments: Device: NexGel

Study type: Interventional

Funder types: Industry

Identifiers

NCT06229080

GuardGel NXG001

Details and patient eligibility

About

Short-acting coloration for normal liver protection in liver cancer patients undergoing radioembolization therapy a study on the effectiveness of all substances

Full description

Patients' liver function can be preserved when delivery of radioembolic agents to the non-tumorous liver is minimized. This is a single-center, single-arm clinical trial to evaluate the efficacy of short-acting embolization particles to temporarily embolize the hepatic arteries toward the non-tumorous liver in patients with hepatocellular carcinoma treated by radioembolization of a large perfused volume. A transient embolic effect will be evaluated by digital subtraction angiography during the procedure. Absorbed doses of the transiently protected non-tumorous liver and unprotected non-tumorous liver will be compared by pre-treatment SPECT-CT (99mTc injection without transient embolization) and post-treatment PET-CT (Y90 injection with transient embolization). In addition, liver volume and function changes for six months will be estimated using gadoxetic acid-enhanced dynamic MRI.

Enrollment: 30 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age > 18-year-old
2. Histologically or radiologically (LI-RADS 4 or 5) diagnosed as hepatocellular carcinoma
3. Patients for whom radioembolization was determined as the optimal treatment after hepatologists', hepatic surgeons' or multidisciplinary clinics.
4. Patients who have not undergone local treatments such as ablation or chemoembolization in the same lobe of the liver within the past year.
5. Child-Pugh class A
6. Eastern Cooperative Oncology Group performance status 0-2
7. Planned perfused area including two or more Couinaud segments based on angiography
8. Non-tumorous liver volume / total perfused area > 50%

Exclusion criteria

1. Hepatocellular carcinoma with vascular invasion on diagnostic imaging
2. History of active cancer other than hepatocellular carcinoma within recent two years
3. Surgical anastomosis of the bile duct and bowel
4. Lung shunt fraction ≥ 15% on 99mTc- macroaggregated albumin lung scan
5. Patients contraindicated to gelatin

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Test group

Experimental group

Description:

short-acting gelatin sponge particles (NexGel) will be administered to the hepatic arteries toward the non-tumorous liver.

Treatment:

Device: NexGel