Modelling Internal Hepatic Movement With an External Abdominal Marker

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00299299
Recruitment Status : Unknown
Verified January 2010 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : March 6, 2006
Last Update Posted : January 12, 2010
Information provided by:
Royal Marsden NHS Foundation Trust

Brief 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.

Condition or disease
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
Estimated Enrollment : 10 participants
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
Study Start Date : June 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00299299

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
Principal Investigator: Dr Diana Tait Royal Marsden HNHS Foundation Trust

Responsible Party: Jane Lawrence, Royal Marsden NHS Foundation Trust Identifier: NCT00299299     History of Changes
Other Study ID Numbers: CCR 2736
First Posted: March 6, 2006    Key Record Dates
Last Update Posted: January 12, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases