Modelling Internal Hepatic Movement With an External Abdominal Marker

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

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.

Study Overview

• Status: Unknown
• Conditions: Patients With Liver Metastases From Colorectal Cancer

Detailed 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".

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• United Kingdom
  • Chelsea, United Kingdom
    • Recruiting
    • Royal Marsden Hospital
    • Principal Investigator: Diana Tait
    • Contact: Diana Tait; Phone Number: 02086613370

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

10 RMH patients aged over 18 years with single or multiple hepatic metastases secondary to colorectal cancer. Metastases at other sites will not be an exclusion criterion. WHO performance status 0, 1 or 2.

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Investigators: Principal Investigator: Dr Diana Tait, Royal Marsden HNHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: June 1, 2006

Study Registration Dates

• First Submitted: March 3, 2006
• First Submitted That Met QC Criteria: March 3, 2006
• First Posted (Estimate): March 6, 2006

Study Record Updates

• Last Update Posted (Estimate): January 12, 2010
• Last Update Submitted That Met QC Criteria: January 11, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CCR 2736