Patients With Liver Metastases From Colorectal CancerNCT00299299
Modelling Internal Hepatic Movement With an External Abdominal Marker
An observational study of Patients With Liver Metastases From Colorectal Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Liver Metastases From Colorectal Cancer
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2006to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden Hospital
Chelsea
Diana Tait, 02086613370
Diana Tait
About this study
Official title: 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.
Read the 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".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Liver Metastases From Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Dr Diana Tait, Principal investigator, Royal Marsden HNHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299299
- Sponsor's protocol ID
- CCR 2736
- Status last verified
- Jan 2010
- First submitted
- 3 Mar 2006
- Last updated
- 12 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modelling Internal Hepatic Movement With an External Abdominal Marker Block for Use With a Real Time Position Monitoring System for Respiratory Gating
- ClinicalTrials.gov ID
- NCT00299299
- Acronym / sponsor ID
- CCR 2736
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2006
- First posted
- 6 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Diana Tait principal investigator
Royal Marsden HNHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Liver Metastases From Colorectal Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010.