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

March 3, 2006
January 11, 2010
June 2006
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Complete list of historical versions of study NCT00299299 on ClinicalTrials.gov Archive Site
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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.

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".

Observational
Time Perspective: Prospective
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Non-Probability Sample

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.

Patients With Liver Metastases From Colorectal Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
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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
Both
18 Years and older
No
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United Kingdom
 
NCT00299299
CCR 2736
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Jane Lawrence, Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
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Principal Investigator: Dr Diana Tait Royal Marsden HNHS Foundation Trust
Royal Marsden NHS Foundation Trust
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP