Lung CancerPhase 1NCT00588328
The Use of Breathing Synchronized CT and PET Scans in Radiation Therapy Treatment Planning
A Phase 1 study testing PET/CT scan in people with Lung Cancer and Non-Hodgkin's Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find out whether a new device can help obtain more accurate CT and PET scans of the lungs and chest tumors and the liver and liver tumors to help in delivering radiation therapy. When we breathe, the amount of air in the lung changes. Lung tumors may also move during breathing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-Hodgkin's Lymphoma
- What is being tested?
- PET/CT scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to May 2010
- Phase
- Phase 1
- 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
- Ability to sign informed consent form indicating investigative nature of this study, in keeping with the policies of the hospital.
- Patients must have thoracic disease visible on a Chest CT scan, or liver disease visible on a abdominal CT scan.
Who cannot join
- Pregnant women are ineligible. A pregnancy test will be performed on each fertile premenopausal female prior to entry into the study.
- Patients with thoracic or liver disease that is not visible on CT scan
- Patients who are unable to follow directions either due to language difficulties or hearing impairment.
- 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
The purpose of this study is to find out whether a new device can help obtain more accurate CT and PET scans of the lungs and chest tumors and the liver and liver tumors to help in delivering radiation therapy. When we breathe, the amount of air in the lung changes. Lung tumors may also move during breathing. Liver tumors may also move with breathing; as the lungs inflate, the liver can be pushed down. A CT scan (a special type of X-ray) is routinely obtained as part of planning for lung or liver radiation therapy. Since patients breathe during this CT scan and their lung or liver tumors move, these CT scans can sometimes be inaccurate. We are now testing a device to only obtain the CT and an additional PET scan while patients are breathing in or out. This will hopefully allow us to deliver radiation with more accuracy.
Read the detailed description
The objectives are to measure the amount of tumor motion with respiration, measure changes in tumor definition with breathing synchronized PET compared to standard free breathing PET, and to determine the fraction of patients whose radiation treatment plans would be modified based on this information. Eligible patients are those receiving radiation treatment for thoracic or liver tumors.
- Conditions
- Lung Cancer, Non-Hodgkin's Lymphoma
- Being tested
- PET/CT scan
- Medical subject headings
- Lung Neoplasms, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT scanDevice
PET/CT scans
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the amount of tumor motion in breathing synchronized CT scans and determine the fraction of patients whose radiation treatment planning margins would be modified based on this information.
Measured: 2 years
Secondary outcomes (1)
To measure changes in tumor definition with breathing synchronized PET compared to standard free breathing PET, and determine the fraction of patients whose radiation treatment plans would be modified based on this information.
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 posted8 Jan 2008 (estimated)
- Study startMar 2000
- Primary completionJul 2008
- Study completionMay 2010
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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kenneth Rosenzweig, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588328
- Sponsor's protocol ID
- 00-008
- Status last verified
- Dec 2015
- First submitted
- 20 Dec 2007
- Last updated
- 24 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Breathing Synchronized CT and PET Scans in Radiation Therapy Treatment Planning
- ClinicalTrials.gov ID
- NCT00588328
- Acronym / sponsor ID
- 00-008
- Conditions
- Lung Cancer, Non-Hodgkin's Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2000
- Primary completion
- Jul 2008 (actual)
- Study completion
- May 2010 (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.
The purpose of this study is to find out whether a new device can help obtain more accurate CT and PET scans of the lungs and chest tumors and the liver and liver tumors to help in delivering radiation therapy. When we breathe, the amount of air in the lung changes. Lung tumors may also move during breathing. Liver tumors may also move with breathing; as the lungs inflate, the liver can be pushed down. A CT scan (a special type of X-ray) is routinely obtained as part of planning for lung or liver radiation therapy. Since patients breathe during this CT scan and their lung or liver tumors move, these CT scans can sometimes be inaccurate. We are now testing a device to only obtain the CT and an additional PET scan while patients are breathing in or out. This will hopefully allow us to deliver radiation with more accuracy.
Detailed description
The objectives are to measure the amount of tumor motion with respiration, measure changes in tumor definition with breathing synchronized PET compared to standard free breathing PET, and to determine the fraction of patients whose radiation treatment plans would be modified based on this information. Eligible patients are those receiving radiation treatment for thoracic or liver tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: PET/CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Ability to sign informed consent form indicating investigative nature of this study, in keeping with the policies of the hospital.
- Patients must have thoracic disease visible on a Chest CT scan, or liver disease visible on a abdominal CT scan.
Key exclusion criteria (4 listed)
- Pregnant women are ineligible. A pregnancy test will be performed on each fertile premenopausal female prior to entry into the study.
- Patients with thoracic or liver disease that is not visible on CT scan
- Patients who are unable to follow directions either due to language difficulties or hearing impairment.
- 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 scanPET/CT scans | Device | 1 |
Primary outcome
To measure the amount of tumor motion in breathing synchronized CT scans and determine the fraction of patients whose radiation treatment planning margins would be modified based on this information.
Time frame: 2 years
1 secondary outcome
To measure changes in tumor definition with breathing synchronized PET compared to standard free breathing PET, and determine the fraction of patients whose radiation treatment plans would be modified based on this information.
Time frame: 2 years
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 24 Dec 2015.
- Related InfoLink 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.
Kenneth Rosenzweig, 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 Phase 1 study testing PET/CT scan in people with Lung Cancer and Non-Hodgkin's Lymphoma, 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 4 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 24 Dec 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 measure the amount of tumor motion in breathing synchronized CT scans and determine the fraction of patients whose radiation treatment planning margins would be modified based on this information. (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 24 Dec 2015.