Lung CancerNCT01109953
Improving Clinical PET/CT Image Quality in Retrospectively Reconstructed Breath-Hold Images
An observational study of Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The patient has been referred for an FDG PET/CT scan. FDG is a form of sugar that contains a small amount of radioactivity; it is used to see the size and possible spread of cancer in the body. Pictures of the body are taken on a machine called a PET/CT scanner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Breath-Hold PET/CT image set
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Mar 2012
- 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 scheduled for whole body FDG PET/CT examination as part of their routine clinical care.
Who may be able to join
- Participant is capable of providing written consent.
- 18 years of age or older.
- Patient with a known or suspected FDG-avid malignancy in the torso
Who cannot join
- none
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
The patient has been referred for an FDG PET/CT scan. FDG is a form of sugar that contains a small amount of radioactivity; it is used to see the size and possible spread of cancer in the body.
Pictures of the body are taken on a machine called a PET/CT scanner. The purpose of this current study is to see if we, the investigators, can take clearer pictures of the tumor than we could with our routine scan method. This would allow us to better see how FDG is picked up by the tumor. PET/CT is presently one of the best tools for detecting cancer and determining its spread in the body. However, due to breathing motion, PET and CT images may become blurred and the location of the tumor on CT and PET images may not match. We have developed a new method that enables us to reduce image blurring and to measure the tumor more accurately on PET images. In this study we want to compare two kinds of images: those from the standard PET/CT scan, and the PET/CT scan pictures taken with our new method.
If successful, we may use this new method for clinical routine in the future.
- Conditions
- Lung Cancer
- Being tested
- Breath-Hold PET/CT image set
- Keywords
- Lung, PET/CT scan, 10-054
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath-Hold PET/CT image setOther
In addition to the standard clinical PET/CT images, we will provide a breath-hold PET/CT image set, using the same PET data for both. In order to spatially match PET, and therefore improve attenuation correction in the PET images, we will acquire a Breath-Hold CT at 310 mA over the same region covered by PET. The normal-organ doses accumulated from the additional 30 mA CT. The patient's breathing signal during CT and the whole body PET will be recorded using a video camera and in house developed software. We will compare the clinical PET/CT and Breath-Hold PET/CT in regards to lesion detection, lesion volume, and SUV quantification.
| Study group | Role | What they receive |
|---|---|---|
| Breath-Hold PET/CT image | In addition to the standard clinical PET/CT images, we will provide a breath-hold PET/CT image set, using the same PET data for both. Receives: Other: Breath-Hold PET/CT image set |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if our breath-hold acquisition technique can be implemented in whole-body PET/CT scans.
Because PET events not satisfying the breathing amplitude selection criteria will be dropped off the final image set, it will be necessary to increase the acquisition time for the FOV's covering the thorax area from 3 min/bed to 5 min/bed to compensate for the reduction in statistics. This should result in a total increase of ~6 min for the whole body scan.
Measured: at the time of scan
Secondary outcomes (1)
To determine if whole body PET/CT improves spatial matching of PET and CT
to compare image quality, blurring, PET-to-CT mis-match, and lesion SUV of the standard PET images with the breath-hold ones.
Measured: at the time of scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heiko Schoder, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109953
- Sponsor's protocol ID
- 10-054
- Status last verified
- Mar 2012
- First submitted
- 20 Apr 2010
- Last updated
- 16 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Clinical PET/CT Image Quality in Retrospectively Reconstructed Breath-Hold Images
- ClinicalTrials.gov ID
- NCT01109953
- Acronym / sponsor ID
- 10-054
- Conditions
- Lung Cancer
- Keywords
- Lung, PET/CT scan, 10-054
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 23 Apr 2010 (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 patient has been referred for an FDG PET/CT scan. FDG is a form of sugar that contains a small amount of radioactivity; it is used to see the size and possible spread of cancer in the body.
Pictures of the body are taken on a machine called a PET/CT scanner. The purpose of this current study is to see if we, the investigators, can take clearer pictures of the tumor than we could with our routine scan method. This would allow us to better see how FDG is picked up by the tumor. PET/CT is presently one of the best tools for detecting cancer and determining its spread in the body. However, due to breathing motion, PET and CT images may become blurred and the location of the tumor on CT and PET images may not match. We have developed a new method that enables us to reduce image blurring and to measure the tumor more accurately on PET images. In this study we want to compare two kinds of images: those from the standard PET/CT scan, and the PET/CT scan pictures taken with our new method.
If successful, we may use this new method for clinical routine in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breath-Hold PET/CT image | – | Other: Breath-Hold PET/CT image setIn addition to the standard clinical PET/CT images, we will provide a breath-hold PET/CT image set, using the same PET data for both. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for whole body FDG PET/CT examination as part of their routine clinical care.
Key inclusion criteria (3 listed)
- Participant is capable of providing written consent.
- 18 years of age or older.
- Patient with a known or suspected FDG-avid malignancy in the torso
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath-Hold PET/CT image setIn addition to the standard clinical PET/CT images, we will provide a breath-hold PET/CT image set, using the same PET data for both. In order to spatially match PET, and therefore improve attenuation correction in the PET images, we will acquire a Breath-Hold CT at 310 mA over the same region covered by PET. The normal-organ doses accumulated from the additional 30 mA CT. The patient's breathing signal during CT and the whole body PET will be recorded using a video camera and in house developed software. We will compare the clinical PET/CT and Breath-Hold PET/CT in regards to lesion detection, lesion volume, and SUV quantification. | Other | Breath-Hold PET/CT image |
Primary outcome
To determine if our breath-hold acquisition technique can be implemented in whole-body PET/CT scans.
Time frame: at the time of scan
Because PET events not satisfying the breathing amplitude selection criteria will be dropped off the final image set, it will be necessary to increase the acquisition time for the FOV's covering the thorax area from 3 min/bed to 5 min/bed to compensate for the reduction in statistics. This should result in a total increase of ~6 min for the whole body scan.
1 secondary outcome
To determine if whole body PET/CT improves spatial matching of PET and CT
Time frame: at the time of scan
Results and safety
The study was stopped early (reason given: Lack of accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
- 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.
Heiko Schoder, 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 Lung Cancer, 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 3 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: stopped early, as of the sponsor's last update on 16 Mar 2012. 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 was stopped early (reason given: Lack of accrual). Results are not available in the source record.
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 determine if our breath-hold acquisition technique can be implemented in whole-body PET/CT scans. (time frame: at the time of scan). 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 16 Mar 2012.