Colon CancerNCT01401309
PET Respiratory Gating to Detect Hepatic Metastasis in Patients With Colon Cancer
An observational study of Colon Cancer, run by Southwestern Regional Medical Center at 1 site in United States.
Trial summary
This study is to examine if there is improved sensitivity in detecting hepatic lesions using respiratory gating and if there is an improvement in confidence defining lesions as benign or malignant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2013
- 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: Patients with colon cancer
Who may be able to join
- Patients with colon cancer
- 18 years or older
- Signed Informed Consent Form
- Blood Glucose of 200 or less prior to scan
Who cannot join
- Patients with known hepatic metastasis
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Treamtent Centers of America at Southwestern Regional Medical Center, Inc
Tulsa, Oklahoma, 74133
About this study
Official title: Effects of Respiratory Gating on FDG/PET Detection of Hepatic Metastasis in Patients With Colon Cancer
This study is to examine if there is improved sensitivity in detecting hepatic lesions using respiratory gating and if there is an improvement in confidence defining lesions as benign or malignant.
- Conditions
- Colon Cancer
- Medical subject headings
- Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Detecting
To exam if there is an improved sensitivity in detecting hepatic lesions using respiratory gating and if there is improvement in confidence defining lesions as benign or malignant
Measured: Jan 2011 - Nov 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2011
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwestern Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401309
- Sponsor's protocol ID
- SRMC 10-07
- Status last verified
- Feb 2014
- First submitted
- 24 Jan 2011
- Last updated
- 21 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Gating on FDG/PET Detection of Hepatic Metastasis in Patients With Colon Cancer
- ClinicalTrials.gov ID
- NCT01401309
- Acronym / sponsor ID
- SRMC 10-07
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Southwestern Regional Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 25 Jul 2011 (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 is to examine if there is improved sensitivity in detecting hepatic lesions using respiratory gating and if there is an improvement in confidence defining lesions as benign or malignant.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colon cancer
Key inclusion criteria (4 listed)
- Patients with colon cancer
- 18 years or older
- Signed Informed Consent Form
- Blood Glucose of 200 or less prior to scan
Key exclusion criteria (1 listed)
- Patients with known hepatic metastasis
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
Detecting
Time frame: Jan 2011 - Nov 2011
To exam if there is an improved sensitivity in detecting hepatic lesions using respiratory gating and if there is improvement in confidence defining lesions as benign or malignant
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 21 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Colon Cancer, run by Southwestern Regional Medical 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 4 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 21 Feb 2014. 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?
Detecting (time frame: Jan 2011 - Nov 2011). 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 21 Feb 2014.