Part of the Modern Art Study

NCT06768242 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: NL86070.078.24
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

One of the possible treatments for patients with liver tumours (hepatocellular carcinoma (HCC) or liver metastases) at the Erasmus MC is stereotactic body radiation therapy (SBRT) on the Cyberknife. To spare the organs at risk, suboptimal coverage of the planning target volume is sometimes accepted. The Ethos treatment system is equipped with a novel cone-beam CT (CBCT), which provides higher quality images. This makes it possible to consider online adaptive radiotherapy with daily plan adaptation, potentially leading to a higher dose on the tumour whilst sparing the surrounding healthy tissue more. Liver tumours move with the breathing motion. On the CyberKnife, a tracking technology is used to keep track of the tumour, but this is not available on the Ethos. Because of this, breath holds will be used for breathing management, but appropriate safety margins need to be established under the new treatment conditions. The aim of this study is to determine the reproducibility of the tumour position for each breath hold within a treatment fraction, and also between treatment fractions, which is a crucial component in the establishment of appropriate safety margins.

Conditions

HCC - Hepatocellular Carcinoma; Liver Metastases

Keywords

HCC - Hepatocellular Carcinoma; Stereotactic body radiation therapy; Breath hold; Liver metastases

Outcome Measures

Primary Outcomes (2)

• Intrafraction fiducial position reproducibility

  The translation in mm in three directions (craniocaudal, left-right and anterior-posterior) of each of the fiducials in the second and third cone beam CT, compared to the first cone beam CT of each session.

  Before or after three radiotherapy sessions over the course of treatment.

• Interfraction fiducial position reproducibility

  The translation in mm in three directions (craniocaudal, left-right and anterior-posterior) of each of the fiducials in each of the imaging sessions, compared to the planning CT that was made before the start of treatment.

  Before or after three radiotherapy sessions over the course of treatment.

Study Arms (1)

Cone beam CT

EXPERIMENTAL

Single-arm study

Radiation: Cone beam CT

Interventions

Cone beam CT RADIATION

Each patient will undergo three cone beam CTs per session, and a total of three sessions.

Cone beam CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent;
• Patient discussed in multidisciplinary tumor board;
• Patient diagnosed with liver metastases and referred to the dept. of Radiotherapy for SBRT OR patient ≥65 years, diagnosed with HCC and referred to the dept. of Radiotherapy for SBRT;
• Able to comply with breath-hold requirements.

You may not qualify if:

• Eligibility for surgery, ablation or liver transplantation.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 CD, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Alejandra Méndez Romero, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandra Méndez Romero, MD, PhD

CONTACT

+31 (0)10 7035792; a.mendezromero@erasmusmc.nl

Linda Chen, MSc

CONTACT

l.chen@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 10, 2025
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)