Metastatic Colorectal CancerNCT00435097
Computer Assisted Early Detection of Liver Metastases From fMRI Maps
An observational study of Metastatic Colorectal Cancer, run by Hadassah Medical Organization at 2 sites in Israel.
Trial summary
The purpose of this protocol is to develop a detailed MRI technique and haemodynamic maps enabling early detection of colorectal metastases in the liver. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- Not given
- Where
- 2 sitesIsrael
- Study dates
- Start not givento 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Control group of healthy volunteers
- Study group: Patients with colon cancer stage III or IV with high suspicion of liver metastases: raising CEA, suspected lesion in the liver by CT or PET.
Who cannot join
- Contraindication to perform MRI.
Trial locations and contacts
2 sites in 1 country.
Ayala Hubert, MD contact
Israel2 sites
Hadassah Medical Organization
Jerusalem, 91120
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Ayala Hubert, MD
Hebrew University
Jerusalem, 96000
Leo Joskowicz, PhD
About this study
The purpose of this protocol is to develop a detailed MRI technique and haemodynamic maps enabling early detection of colorectal metastases in the liver.
Read the detailed description
In this research, we propose to develop methods and protocols for imaging-based, non-invasive early detection and diagnosis of colon cancer metastases. Colon cancer is the third most common cancer worldwide. While it is amenable to surgery if detected early, advanced carcinomas are usually lethal, with liver metastases being the most common cause of death. Early and accurate detection of these lesions is recognized as having the potential of improving survival rates and reducing treatment morbidity. Current diagnostic imaging offers improved discrimination and sensitivity that can be used for earlier detection of smaller lesions conducive to curative therapy.
In previous research, we demonstrated the feasibility of fMRI based on hypercapnia and hyperoxia for monitoring changes in liver perfusion and hemodynamics without contrast agent administration. The isolation and analysis of areas with significant hemodynamical changes in images acquired at early phase of tumor development has proven to be a difficult, time consuming, and potentially unreliable task. Our goal is thus two-fold: 1. use image processing and machine learning tools on a training set of hemodynamical maps obtained from well validated tumors to automate the process and improve its discrimination and sensitivity characteristics, and; 2. implement our method in patients with colorectal liver metastases. The method can help general radiologists with no image processing training to highlight undetectable tumors from background noise and increase diagnosis specificity and sensitivity.
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- colon cancer, metastatic colorectal cancer, MRI, Magnetic resonance imaging, Early cancer detection, medical image processing, machine learning, disease modeling, Colon Cancer Stage III
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Observational model
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Ayala Hubert, MD, Principal investigator, Hadassah Medical OrganizationAbramovitch Rinat, PhD, Principal investigator, Hadassah Medical OrganizationJoskowicz Leo, PhD, Principal investigator, Hebrew University, Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435097
- Sponsor's protocol ID
- colmri-HMO-CTIL
- Status last verified
- Feb 2007
- First submitted
- 13 Feb 2007
- Last updated
- 14 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Assisted Early Detection of Liver Metastases From fMRI Maps
- ClinicalTrials.gov ID
- NCT00435097
- Acronym / sponsor ID
- colmri-HMO-CTIL
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- colon cancer, metastatic colorectal cancer, MRI, Magnetic resonance imaging, Early cancer detection, medical image processing, machine learning, disease modeling
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 14 Feb 2007 (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.
The purpose of this protocol is to develop a detailed MRI technique and haemodynamic maps enabling early detection of colorectal metastases in the liver.
Detailed description
In this research, we propose to develop methods and protocols for imaging-based, non-invasive early detection and diagnosis of colon cancer metastases. Colon cancer is the third most common cancer worldwide. While it is amenable to surgery if detected early, advanced carcinomas are usually lethal, with liver metastases being the most common cause of death. Early and accurate detection of these lesions is recognized as having the potential of improving survival rates and reducing treatment morbidity. Current diagnostic imaging offers improved discrimination and sensitivity that can be used for earlier detection of smaller lesions conducive to curative therapy.
In previous research, we demonstrated the feasibility of fMRI based on hypercapnia and hyperoxia for monitoring changes in liver perfusion and hemodynamics without contrast agent administration. The isolation and analysis of areas with significant hemodynamical changes in images acquired at early phase of tumor development has proven to be a difficult, time consuming, and potentially unreliable task. Our goal is thus two-fold: 1. use image processing and machine learning tools on a training set of hemodynamical maps obtained from well validated tumors to automate the process and improve its discrimination and sensitivity characteristics, and; 2. implement our method in patients with colorectal liver metastases. The method can help general radiologists with no image processing training to highlight undetectable tumors from background noise and increase diagnosis specificity and sensitivity.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Control group of healthy volunteers
- Study group: Patients with colon cancer stage III or IV with high suspicion of liver metastases: raising CEA, suspected lesion in the liver by CT or PET.
Key exclusion criteria (1 listed)
- Contraindication to perform MRI.
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 14 Feb 2007.
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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.
Ayala Hubert, MD contact
Ayala Hubert, MD principal investigator
Hadassah Medical Organization
Abramovitch Rinat, PhD principal investigator
Hadassah Medical Organization
Joskowicz Leo, PhD principal investigator
Hebrew University, Jerusalem
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Hadassah Medical Organization at 2 sites in Israel.
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 2 inclusion and 1 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 14 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Contact Ayala Hubert, MD (ayalah@hadassah.org.il), or a site near the patient. 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 14 Feb 2007.