Modelling Internal Hepatic Movement With an External Abdominal Marker

Patients With Liver Metastases From Colorectal Cancer Clinical Trial

Official title:

Modelling Internal Hepatic Movement With an External Abdominal Marker Block for Use With a Real Time Position Monitoring System for Respiratory Gating

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00299299
• Other study ID #: CCR 2736
• Status: Recruiting
• Phase: N/A
• First received: March 3, 2006
• Last updated: January 11, 2010
• Start date: June 2006

Study information

• Verified date: January 2010
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

This study tests the feasibility and reproducibility of patient-specific motion models. These will be used for quantification of safe margin reduction. Patient-specific motion models will be built by post-processing 4D MRI data with non-rigid registration. By comparing these models between visits, model reproducibility will be assessed, and the methodology refined.

Description:

The study will use a real time position management (RPM) system for respiratory gating. The RPM system senses the respiration motion of the patient by tracking a pair of reflective markers on a lightweight "marker block" constructed of a synthetic material. This block is placed on the patient's abdomen.

During Radiotherapy, the beam is only switched on at pre-determined phases of respiration. The appropriate phase of respiration is determined by the RPM system. This implies a reliable correlation of external block motion to internal hepatic movement. This correlation is not a simple one, and requires "modeling".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed adenocarcinoma compatible with primary disease in the colon or rectum

• Aged 18 years or older

• Unequivocal contrast-enhanced CT and/or MRI evidence of malignant single or multiple metastases in the liver, metastases at other sites will not be an exclusion criterion

• WHO performance status 0-2 and life expectancy of at least 12 weeks

• Informed written consent

Exclusion Criteria:

• Pregnancy or breast feeding

• Evidence of ascites

• Patients unable for whatever reason to lie flat

• Patients unable to give fully informed consent

• Age< 18 years

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Patients With Liver Metastases From Colorectal Cancer

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hospital	Chelsea

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom,