SHEPHERD(SHort-acting Embolization Particles for Patients With HEpatocellular Carcinoma Treated by RaDioembolization)

N

Nextbiomedical

Status

Enrolling

Conditions

Hepatocellular Carcinoma

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. Treatment-naive patients
  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. Hepatocellular carcinoma with extrahepatic spread on diagnostic imaging
  3. History of active cancer other than hepatocellular carcinoma within recent two years
  4. Surgical anastomosis of the bile duct and bowel
  5. Lung shunt fraction ≥ 15% on 99mTc- macroaggregated albumin lung scan
  6. 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

Trial contacts and locations

1

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Central trial contact

Jin Woo Choi

Data sourced from clinicaltrials.gov

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