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

Hepatocellular Carcinoma Clinical Trial

Official title:

Short-acting Embolization Particles for Patients With HEpatocellular Carcinoma Treated by RaDioembolization (SHEPHERD): a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229080
• Other study ID #: GuardGel NXG001
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Next Biomedical Co., Ltd.
• Contact: Jin Woo Choi
• Phone: +82-32-454-4800
• Email: next[@]nextbiomedical.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• NexGel
When a planned perfused area includes three or more Couinaud segments and more than 50% of the target area is non-tumorous liver, short-acting gelatin sponge particles (NexGel) will be administered to the hepatic arteries toward the non-tumorous liver. The embolization particles will be prepared by mixing one vial of the particles with 5 mL of iodinated contrast agents and intra-arterially delivered with a microcatheter 2.0-Fr or larger. After confirming the disappearance or substantial reduction of liver parenchymal staining of the embolized area on angiography, radioembolization using Y90 glass or resin microspheres will be conducted. Digital subtraction angiography will be performed 30 minutes after the transient embolization to identify recanalization of the transiently embolized hepatic arteries.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Gwanak-gu

Sponsors (1)

Lead Sponsor	Collaborator
Next Biomedical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver	Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver	The day after radioembolization
Secondary	Angiographic recanalization of the transiently embolized hepatic arteries	Angiographic recanalization of the transiently embolized hepatic arteries(After 30 minutes of Nexgel embolization, the resumption of the blood vessels is qualitatively evaluated (0 points: not reopened at all ~ 4 points: fully reopened) by an independent radiologist's angiography reading.)	30 minutes after embolization
Secondary	Tumor-to-normal liver ratio change between the pre-treatment SPECT-CT (99mTc-MAA injection without transient embolization) and post-treatment PET-CT (Y90 injection with transient embolization)	Tumor-to-normal liver ratio change between the pre-treatment SPECT-CT (99mTc-MAA injection without transient embolization) and post-treatment PET-CT (Y90 injection with transient embolization)	The day after radioembolization
Secondary	Ratio of the Relative volumetric changes between the protected perfused liver and unprotected perfused liver	Ratio of the Relative volumetric changes between the protected perfused liver and unprotected perfused liver	Six months after radioembolization
Secondary	Relative signal intensity ratio between the protected perfused liver and unprotected perfused liver on a 20-minute delayed scan of gadoxetic acid-enhanced MRI	Relative signal intensity ratio between the protected perfused liver and unprotected perfused liver on a 20-minute delayed scan of gadoxetic acid-enhanced MRI	Six months after radioembolization
Secondary	Response to the treatment, as assessed by mRECIST	Objective Tumour Response will be assessed by the investigators on CT/MRI image analysis	Six months after radioembolization
Secondary	Serious adverse event	Serious adverse event	For six months from radioembolization