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

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

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

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Device: NexGel

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jin Woo Choi; Phone Number: +82-32-454-4800; Email: next@nextbiomedical.co.kr

Study Locations

• Korea, Republic of
  • Gwanak-gu
    • Seoul, Gwanak-gu, Korea, Republic of, 1, Gwanak-ro
      • Recruiting
      • Seoul National University Hospital
      • Contact: Jin Woo Choi; Phone Number: +82-32-454-4800
      • Contact: Email: next@nextbiomedical.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Serious adverse event	Serious adverse event	For six months from radioembolization
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

Collaborators and Investigators

• Sponsor: Next Biomedical Co., Ltd.
• Investigators: Principal Investigator: Jin Woo Choi, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: GuardGel NXG001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No