## Protocol Section
### Identification Module
**NCT ID:** NCT06426992

**Brief Title:** Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic Malignancies

**Official Title:** Evaluation of Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Small Liver Malignancies: A Prospective Single Center Study

#### Organization Study ID Info
**ID:** 2402-111-151
#### Organization
**Class:** OTHER
**Full Name:** Seoul National University Hospital
### Status Module
#### Completion Date
**Date:** 2026-03-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-03-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-30

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Seoul National University Hospital

#### Responsible Party

**Investigator Affiliation:** Seoul National University Hospital

**Investigator Full Name:** Jeong Min Lee

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to determine the technical success rate of creating a safety margin of 5 mm or more including the tumor by performing image-guided percutaneous microwave thermal therapy using a microwave generator and antenna developed by StarMed for the treatment of small liver cancer and the 1-year local recurrence rate based on follow-up imaging tests.

### Conditions Module

**Conditions:**

- Liver Malignant Tumors

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 62

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Following the existing procedure of our institute, we aim to treat the tumor by applying up to 150W of microwaves within the tumor using a StarWave microwave generator and a 13-gauge antenna under fusion ultrasound guidance. If necessary, the antenna is reinserted 1-2 times to create sufficient ablation lesions until an echogenic band of 5-10mm is formed around the tumor and its periphery, implementing overlapping microwave ablation (MWA). Afterward, the antenna is removed while applying microwave energy to prevent bleeding.

**Intervention Names:**

- Procedure: Microwave ablation

**Label:** Patients with malignant liver tumors

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients with malignant liver tumors

**Description:** Following the existing procedure of our institute, we aim to treat the tumor by applying up to 150W of microwaves within the tumor using a StarWave microwave generator and a 13-gauge antenna under fusion ultrasound guidance. If necessary, the antenna is reinserted 1-2 times to create sufficient ablation lesions until an echogenic band of 5-10mm is formed around the tumor and its periphery, implementing overlapping microwave ablation (MWA). Afterward, the antenna is removed while applying microwave energy to prevent bleeding.

**Name:** Microwave ablation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone.

**Measure:** Technical success

**Time Frame:** Immediately after ablation

**Description:** Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success

**Measure:** Local tumor progression rate

**Time Frame:** 12 months after ablation

#### Secondary Outcomes

**Description:** Post ablation complications were defined as problems noted within 1 month after MWA as well as additional complications identified on follow-up imaging and judged to be likely caused by ablation.

**Measure:** Complication after ablation

**Time Frame:** Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation

**Description:** Recurrence-free survival was defined as the interval between ablation and the date of any type of recurrence or the last follow-up date if there was no recurrence.

**Measure:** Recurrence-free survival

**Time Frame:** 12 months after ablation

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Child-Pugh Class A or B
* Patients with suspected hepatocellular carcinoma or residual/recurrent hepatocellular carcinoma of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days or Patients with suspected metastatic liver cancer of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days, for whom microwave thermal ablation is being considered

Exclusion Criteria:

* In cases where there are three or more malignant liver tumors
* When the maximum size of the tumor exceeds 4 cm
* Diffuse infiltrative type of cancer with unclear tumor boundaries
* When the tumor is adhered to the central hepatic portal vein, hepatic vein, or bile duct by 5 mm or more
* Severe liver failure (Child-Pugh Class C)
* In cases of vascular invasion by malignant liver tumors
* Severe coagulopathy (platelet count below 50,000/mm³ or INR prolonged by more than 50%)
* In cases of multiple extrahepatic metastases
* Situations where it is highly unlikely to obtain appropriate data for research purposes

**Maximum Age:** 85 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** redlion55@naver.com

**Name:** Hyun Hee Lee

**Phone:** 82-2-2072-4177

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Email:** redlion55@naver.com

- **Name:** Hyun Hee Lee

- **Phone:** 82-2-2072-4177

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jeong Min Lee, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Korea, Republic of

**Facility:** Seoul National University Hospital

**Status:** RECRUITING

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000008107

- Term: Liver Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11113

- Name: Liver Neoplasms

- Relevance: HIGH

- As Found: Liver Malignant Tumors

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008113

- Term: Liver Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
