Colorectal CarcinomaNCT00588549
Utility of PET In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases
An observational study of Colorectal Carcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study aims to determine whether a test, called the PET scan, may be useful in determining if there are additional locations of cancer not otherwise detectable by other tests. The PET scan is a nuclear medicine imaging study that measures how much radioactive sugar is used by your tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1998to Mar 2009
- 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: Memorial Sloan-Kettering Cancer Center patients with colorectal cancer
Who may be able to join
- initial diagnosis of colorectal carcinoma confirmed by the Pathology Department of Memorial Hospital or by diagnostic barium enema if the primary tumor is still in place.
- a candidate for liver resection for metastatic colorectal cancer as defined by members of the Department of Surgery of Memorial Hospital. Patients with metastatic colorectal cancer isolated to the colon, rectum, or liver are eligible. In addition, patients with limited, resectable pulmonary metastases are eligible.
Who cannot join
- Patients must not be pregnant; females of child bearing age must use an adequate form of contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Utility of Whole-Body 18-Fluorodeoxyglucose Positron Emission Tomography (PET) In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases
This study aims to determine whether a test, called the PET scan, may be useful in determining if there are additional locations of cancer not otherwise detectable by other tests.
The PET scan is a nuclear medicine imaging study that measures how much radioactive sugar is used by your tumor. The study will compare pictures of the cancer from the PET scan to other x-ray exams, such as a CT scan, as well as to what your doctors find at the time of surgery. If the study results show that the PET scan gives us a good idea of what is happening to the tumor, then it may be useful in deciding which patients with colorectal metastases to the liver should be operated on and what operation should be performed.
Additionally, by comparing the results of PET scans with the other studies that will be performed as part of your care, we will try to determine which test best tells us which patient is most likely to benefit from surgery.
- Conditions
- Colorectal Carcinoma
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess if whole body 18F-FDG-PET enhances our ability to detect metastatic colorectal cancer restricted to liver and lung over conventional imaging such as CT and to determine the accuracy of PET in imaging extrahepatic tumors.
Measured: conclusion of the study
Secondary outcomes (1)
To determine whether PET plays a role in altering clinical management of patients undergoing evaluation for liver resection for hepatic colorectal metastases.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startJul 1998
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Yuman Fong, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588549
- Sponsor's protocol ID
- 98-015
- Status last verified
- Mar 2009
- First submitted
- 24 Dec 2007
- Last updated
- 19 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Whole-Body 18-Fluorodeoxyglucose Positron Emission Tomography (PET) In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases
- ClinicalTrials.gov ID
- NCT00588549
- Acronym / sponsor ID
- 98-015
- Conditions
- Colorectal Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jul 1998
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 8 Jan 2008 (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 aims to determine whether a test, called the PET scan, may be useful in determining if there are additional locations of cancer not otherwise detectable by other tests.
The PET scan is a nuclear medicine imaging study that measures how much radioactive sugar is used by your tumor. The study will compare pictures of the cancer from the PET scan to other x-ray exams, such as a CT scan, as well as to what your doctors find at the time of surgery. If the study results show that the PET scan gives us a good idea of what is happening to the tumor, then it may be useful in deciding which patients with colorectal metastases to the liver should be operated on and what operation should be performed.
Additionally, by comparing the results of PET scans with the other studies that will be performed as part of your care, we will try to determine which test best tells us which patient is most likely to benefit from surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Memorial Sloan-Kettering Cancer Center patients with colorectal cancer
Key inclusion criteria (2 listed)
- initial diagnosis of colorectal carcinoma confirmed by the Pathology Department of Memorial Hospital or by diagnostic barium enema if the primary tumor is still in place.
- a candidate for liver resection for metastatic colorectal cancer as defined by members of the Department of Surgery of Memorial Hospital. Patients with metastatic colorectal cancer isolated to the colon, rectum, or liver are eligible. In addition, patients with limited, resectable pulmonary metastases are eligible.
Key exclusion criteria (1 listed)
- Patients must not be pregnant; females of child bearing age must use an adequate form of contraception.
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
To assess if whole body 18F-FDG-PET enhances our ability to detect metastatic colorectal cancer restricted to liver and lung over conventional imaging such as CT and to determine the accuracy of PET in imaging extrahepatic tumors.
Time frame: conclusion of the study
1 secondary outcome
To determine whether PET plays a role in altering clinical management of patients undergoing evaluation for liver resection for hepatic colorectal metastases.
Time frame: conclusion of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2009.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Yuman Fong, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Colorectal Carcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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: finished, as of the sponsor's last update on 19 Mar 2009. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess if whole body 18F-FDG-PET enhances our ability to detect metastatic colorectal cancer restricted to liver and lung over conventional imaging such as CT and to determine the accuracy of PET in imaging extrahepatic tumors. (time frame: conclusion of the study). It is what the study was designed to measure, not a finding.
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 19 Mar 2009.