Modelling Internal Hepatic Movement With an External Abdominal Marker

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00299299
First received: March 3, 2006
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

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.


Condition
Patients With Liver Metastases From Colorectal Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Modelling Internal Hepatic Movement With an External Abdominal Marker Block for Use With a Real Time Position Monitoring System for Respiratory Gating

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Estimated Enrollment: 10
Study Start Date: June 2006
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".

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299299

Locations
United Kingdom
Royal Marsden Hospital Recruiting
Chelsea, United Kingdom
Contact: Diana Tait    02086613370      
Principal Investigator: Diana Tait         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Dr Diana Tait Royal Marsden HNHS Foundation Trust
  More Information

No publications provided

Responsible Party: Jane Lawrence, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00299299     History of Changes
Other Study ID Numbers: CCR 2736
Study First Received: March 3, 2006
Last Updated: January 11, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases

ClinicalTrials.gov processed this record on September 11, 2014