Lung CancerNCT01052766
Breathing Synchronized PET/CT Scans for the Detection of Malignant Lung & Liver Lesions and Assessment of Tumor Glycolysis
A study testing PET/CT and BH PET/CT in people with Lung Cancer and Non-small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
In this particular study the physicians want to use a new technique of how they obtain the PET/CT pictures. It is called breath-hold (BH) PET/CT". As the name suggests, they will ask the patient to hold their breath for about 20-30 seconds, and only during that time will they obtain pictures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell Lung Cancer
- What is being tested?
- PET/CT and BH PET/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Mar 2012
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years old
- Patients with early stage biopsy-proven lung cancer or patients with lung or liver metastases from any primary cancer (metastatic disease proven by biopsy, or clearly established clinically and by imaging studies who are being treated with stereotactic body radiotherapy (SBRT)or an ablation will be eligible.
- Patient has at least one lesion ≥ 1cm in size.
- Signed informed consent
Who cannot join
- Pregnant women are ineligible.
- Patients who are unable to follow breathing instructions either due to language difficulties or hearing impairment This will be determined either by one of the consenting individuals when they approach the patient to ask for informed consent or prior to acquisition of the clinical PET/CT.
- Patients who are too ill to hold their breath.
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: The Use of Breathing Synchronized PET/CT Scans for the Detection of Malignant Lung and Liver Lesions and Assessment of Tumor Glycolysis
In this particular study the physicians want to use a new technique of how they obtain the PET/CT pictures. It is called breath-hold (BH) PET/CT". As the name suggests, they will ask the patient to hold their breath for about 20-30 seconds, and only during that time will they obtain pictures. This is repeated several times. In contrast to the standard PET/CT scan, they expect less "blurring" of the pictures, so that they can see the tumor better and measure the uptake of radioactive sugar in the tumor better and more reliably. Basically, this is the difference between taking pictures of a runner as compared to taking pictures of a person standing still. Since PET images need to be obtained over several minutes and people can not hold their breath for this extended time, we break the procedure into several cycles of 20-30 seconds (or longer, if possible) and then add all the "frozen" pictures in the end into one. They want to know if BH PET/CT scan measure changes in the cancer during therapy (i.e., from the baseline scan before therapy to the follow up scan at within 4 weeks later).
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Being tested
- PET/CT and BH PET/CT
- Keywords
- lung cancer, PET Scan, CT Scan, BH-PET scan, 09-134
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT and BH PET/CTProcedure or surgery
First, fiducial markers will be placed and taped on the patient's lower chest/upper abdomen. This will allow for monitoring of chest motion during breathing. A BH-CT scan will then be acquired with clinical CT scan parameters used in nuclear medicine. A BH-PET scan (acquisition time: 6 min per bed position) will follow the BH-CT scan. BH-PET images will cover the whole thorax, which, on average, corresponds to 1-3 PET FOV's (~15 cm/FOV). Data for these 1-3 bed positions are acquired to cover the entire thorax. There will be no additional radiotracer injection for the BH-PET scan.
| Study group | Role | What they receive |
|---|---|---|
| PET/CT and BH PET/CT | Experimental | In collaboration with the Department of Radiation Oncology and the Interventional Radiology Service, patients with lung or liver cancer or lung or liver metastases in whom FDG PET/CT is part of the clinical standard of care for disease evaluation and response assessment will be enrolled in this study. We will perform a clinical PET/CT and BH PET/CT (for two bed positions covering the entire chest) prior to, and again 1-2 weeks after SBRT or RFA. This early time point is chosen because a few weeks after the completion of treatment, acute radiation injury in the lung begins and will likely be detectable as abnormal uptake on follow-up PET imaging making it difficult to assess tumor recurrence. Receives: Procedure: PET/CT and BH PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate whether BH-PET scan improves detectability of the lung & liver lesions seen on breath-hold CT scans as compared to their detectability on standard clinical PET scan.
Measured: 2 years
Secondary outcomes (2)
To compare the magnitude of changes in SUV between pre and post therapy pet scans done as either standard clinical PET/CT or BH PET/CT.
Measured: 2 years
To investigate whether the correlation between change in SUV and the lesion response on follow-up scan (3 months) is different for standard clinical PET/CT versus BH scan.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startJan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Heiko Schoder, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052766
- Sponsor's protocol ID
- 09-134
- Status last verified
- Mar 2012
- First submitted
- 18 Jan 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
- The Use of Breathing Synchronized PET/CT Scans for the Detection of Malignant Lung and Liver Lesions and Assessment of Tumor Glycolysis
- ClinicalTrials.gov ID
- NCT01052766
- Acronym / sponsor ID
- 09-134
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Keywords
- lung cancer, PET Scan, CT Scan, BH-PET scan, 09-134
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Jan 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Jan 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.
In this particular study the physicians want to use a new technique of how they obtain the PET/CT pictures. It is called breath-hold (BH) PET/CT". As the name suggests, they will ask the patient to hold their breath for about 20-30 seconds, and only during that time will they obtain pictures. This is repeated several times. In contrast to the standard PET/CT scan, they expect less "blurring" of the pictures, so that they can see the tumor better and measure the uptake of radioactive sugar in the tumor better and more reliably. Basically, this is the difference between taking pictures of a runner as compared to taking pictures of a person standing still. Since PET images need to be obtained over several minutes and people can not hold their breath for this extended time, we break the procedure into several cycles of 20-30 seconds (or longer, if possible) and then add all the "frozen" pictures in the end into one. They want to know if BH PET/CT scan measure changes in the cancer during therapy (i.e., from the baseline scan before therapy to the follow up scan at within 4 weeks later).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT and BH PET/CT | Experimental | Procedure: PET/CT and BH PET/CTIn collaboration with the Department of Radiation Oncology and the Interventional Radiology Service, patients with lung or liver cancer or lung or liver metastases in whom FDG PET/CT is part of the clinical standard of care for disease evaluation and response assessment will be enrolled in this study. We will perform a clinical PET/CT and BH PET/CT (for two bed positions covering the entire chest) prior to, and again 1-2 weeks after SBRT or RFA. This early time point is chosen because a few weeks after the completion of treatment, acute radiation injury in the lung begins and will likely be detectable as abnormal uptake on follow-up PET imaging making it difficult to assess tumor recurrence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Patients with early stage biopsy-proven lung cancer or patients with lung or liver metastases from any primary cancer (metastatic disease proven by biopsy, or clearly established clinically and by imaging studies who are being treated with stereotactic body radiotherapy (SBRT)or an ablation will be eligible.
- Patient has at least one lesion ≥ 1cm in size.
- Signed informed consent
Key exclusion criteria (3 listed)
- Pregnant women are ineligible.
- Patients who are unable to follow breathing instructions either due to language difficulties or hearing impairment This will be determined either by one of the consenting individuals when they approach the patient to ask for informed consent or prior to acquisition of the clinical PET/CT.
- Patients who are too ill to hold their breath.
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 |
|---|---|---|
| PET/CT and BH PET/CTFirst, fiducial markers will be placed and taped on the patient's lower chest/upper abdomen. This will allow for monitoring of chest motion during breathing. A BH-CT scan will then be acquired with clinical CT scan parameters used in nuclear medicine. A BH-PET scan (acquisition time: 6 min per bed position) will follow the BH-CT scan. BH-PET images will cover the whole thorax, which, on average, corresponds to 1-3 PET FOV's (~15 cm/FOV). Data for these 1-3 bed positions are acquired to cover the entire thorax. There will be no additional radiotracer injection for the BH-PET scan. | Procedure or surgery | PET/CT and BH PET/CT |
Primary outcome
To investigate whether BH-PET scan improves detectability of the lung & liver lesions seen on breath-hold CT scans as compared to their detectability on standard clinical PET scan.
Time frame: 2 years
2 secondary outcomes
To compare the magnitude of changes in SUV between pre and post therapy pet scans done as either standard clinical PET/CT or BH PET/CT.
Time frame: 2 years
To investigate whether the correlation between change in SUV and the lesion response on follow-up scan (3 months) is different for standard clinical PET/CT versus BH scan.
Time frame: 2 years
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?
A study testing PET/CT and BH PET/CT in people with Lung Cancer and Non-small Cell 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 4 inclusion and 3 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 investigate whether BH-PET scan improves detectability of the lung & liver lesions seen on breath-hold CT scans as compared to their detectability on standard clinical PET scan. (time frame: 2 years). 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.