Gastric CancerNCT01213004
Evaluation of Respiratory Motion-Corrected Cone-Beam CT in Radiation Treatment of Thoracic and Abdominal Cancers
A study testing respiration correlated CT scan in people with Gastric Cancer and Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Tumors must be seen clearly on CT scan to be radiated completely and safely. Breathing causes tumors to move. If the tumor moves during breathing, it can look blurred on the CT scan. This makes it difficult to see on CT scan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Lung Cancer
- What is being tested?
- respiration correlated CT scan
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Feb 2018
- 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
- Patients must have histologic proof of a thoracic or abdominal malignancy, confirmed at MSKCC and suitable for radiation therapy, in order to be eligible for this study. Thoracic malignancies (study group 1) include those in lung and gastro-esophageal junction. Abdominal malignancies (study group 2) include those in liver and pancreas. Patients having both thoracic and abdominal malignancies will be placed in only one of the study groups, because the limited field-of-view of the CBCT precludes imaging of both malignancies in the same scan. Patients must be older than 18 years of age
- At least part of the tumor must be visible as observed in a diagnostic or planning CT. The tumor must exhibit at least 5 mm motion from respiration as observed in the respiration-correlated CT (RCCT) at simulation. The RCCT scan must be interpretable and not exhibit excessive motion artifacts caused by irregular patient breathing.
- Patients must have Karnofsky Performance Status ≥ 70%
Who cannot join
- Mesothelioma and other tumors of the pleura
- Pregnant Women
- Allergic to iodine or intravenous contrast agent (applies only to patients with a pancreas or liver malignancy)
- Renal impairment due to the use of a contrast agent
- Patients with pacemakers and defibrillators
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
Tumors must be seen clearly on CT scan to be radiated completely and safely. Breathing causes tumors to move. If the tumor moves during breathing, it can look blurred on the CT scan. This makes it difficult to see on CT scan. The investigators wish to investigate whether a new computer method makes tumors less blurry and easier to see on CT scan. Cone-beam CT is a type of CT scanner attached to the radiation treatment machine that produces 3D images of the patient. Since your tumor can move because of your normal breathing, it is often blurry and difficult to see accurately in a standard cone-beam CT scan. The investigators intend to use a computer method which processes the cone-beam CT data in a way that reduces the blurring and makes the tumor easier to see.
- Conditions
- Gastric Cancer, Lung Cancer
- Being tested
- respiration correlated CT scan
- Keywords
- gastro-esophageal junction, lung, abdominal, cone-beam CT (CBCT), 10-146
- Medical subject headings
- Stomach Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiration correlated CT scanProcedure or surgery
Thoracic malignancies (study group 1): Patients to be treated for gastro-esophageal junction (GEJ) malignancy undergo an implantation procedure of two or three radiopaque markers several days prior to treatment simulation, which are used to correct patient position at treatment. At treatment simulation, patients receive a standard CT scan followed by an RCCT scan. In cases of GEJ malignancy, oral contrast is administered prior to the standard CT scan; this is done at the treating physician's discretion. The standard CT is used to design the radiation treatment plan, where as the RCCT is used to define a volume that encompasses the motion extent of the tumor with breathing and is transferred to the standard CT.
respiration correlated CT scanProcedure or surgery
Abdominal malignancies (study group 2): Patients undergo an implantation procedure of two or three radiopaque markers several days prior to treatment simulation. At treatment simulation, patients receive a standard CT scan followed by an RCCT scan. Intravenous contrast is administered prior to the standard CT; this is done at the treating physician's discretion.
| Study group | Role | What they receive |
|---|---|---|
| thoracic (study group 1) malignancies | Experimental | On the same day as the CBCT scans and treatment session, patients will receive a research-only respiration correlated CT (RCCT scan), for calculating motion-corrected CBCT. The localization accuracy of motion-corrected CBCT using same-day RCCT will be compared to that using the standard RCCT from simulation. Receives: Procedure: respiration correlated CT scan |
| abdominal (study group 2) malignancies | Experimental | On the same day as the CBCT scans and treatment session, patients will receive a research-only respiration correlated CT (RCCT scan), for calculating motion-corrected CBCT. The localization accuracy of motion-corrected CBCT using same-day RCCT will be compared to that using the standard RCCT from simulation. Receives: Procedure: respiration correlated CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether motion-corrected cone-beam CT (CBCT) improves the localization accuracy
of thoracic tumors (evaluated using study group 1) and organs-at-risk (evaluated using study group 2) relative to the standard cone-beam CT procedure.
Measured: 2 years
To determine whether motion-corrected cone-beam CT (CBCT) can visualize and localize abdominal tumors using intravenous contrast enhancement.
(evaluated using study group 2).
Measured: 2 years
Secondary outcomes (2)
To determine whether motion-corrected cone-beam CT (CBCT) derived from a respiration correlated CT (RCCT) scan on the same day improves localization accuracy
for thoracic tumors (evaluated using study group 1) and organs-at-risk (evaluated using study group 2), relative to motion-corrected CBCT derived from a prior RCCT scan at patient's simulation.
Measured: 2 years
To determine whether tumor and organ-at-risk positions localized in cone-beam CT (CBCT)
prior to treatment remain constant throughout the treatment fraction.
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 posted1 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Gikas Mageras, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213004
- Sponsor's protocol ID
- 10-146
- Status last verified
- Feb 2018
- First submitted
- 29 Sep 2010
- Last updated
- 6 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Respiratory Motion-Corrected Cone-Beam CT in Radiation Treatment of Thoracic and Abdominal Cancers
- ClinicalTrials.gov ID
- NCT01213004
- Acronym / sponsor ID
- 10-146
- Conditions
- Gastric Cancer, Lung Cancer
- Keywords
- gastro-esophageal junction, lung, abdominal, cone-beam CT (CBCT), 10-146
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Varian Medical Systems
- Study start
- Sep 2010
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 1 Oct 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.
Tumors must be seen clearly on CT scan to be radiated completely and safely. Breathing causes tumors to move. If the tumor moves during breathing, it can look blurred on the CT scan. This makes it difficult to see on CT scan. The investigators wish to investigate whether a new computer method makes tumors less blurry and easier to see on CT scan. Cone-beam CT is a type of CT scanner attached to the radiation treatment machine that produces 3D images of the patient. Since your tumor can move because of your normal breathing, it is often blurry and difficult to see accurately in a standard cone-beam CT scan. The investigators intend to use a computer method which processes the cone-beam CT data in a way that reduces the blurring and makes the tumor easier to see.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thoracic (study group 1) malignancies | Experimental | Procedure: respiration correlated CT scanOn the same day as the CBCT scans and treatment session, patients will receive a research-only respiration correlated CT (RCCT scan), for calculating motion-corrected CBCT. The localization accuracy of motion-corrected CBCT using same-day RCCT will be compared to that using the standard RCCT from simulation. |
| abdominal (study group 2) malignancies | Experimental | Procedure: respiration correlated CT scanOn the same day as the CBCT scans and treatment session, patients will receive a research-only respiration correlated CT (RCCT scan), for calculating motion-corrected CBCT. The localization accuracy of motion-corrected CBCT using same-day RCCT will be compared to that using the standard RCCT from simulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have histologic proof of a thoracic or abdominal malignancy, confirmed at MSKCC and suitable for radiation therapy, in order to be eligible for this study. Thoracic malignancies (study group 1) include those in lung and gastro-esophageal junction. Abdominal malignancies (study group 2) include those in liver and pancreas. Patients having both thoracic and abdominal malignancies will be placed in only one of the study groups, because the limited field-of-view of the CBCT precludes imaging of both malignancies in the same scan. Patients must be older than 18 years of age
- At least part of the tumor must be visible as observed in a diagnostic or planning CT. The tumor must exhibit at least 5 mm motion from respiration as observed in the respiration-correlated CT (RCCT) at simulation. The RCCT scan must be interpretable and not exhibit excessive motion artifacts caused by irregular patient breathing.
- Patients must have Karnofsky Performance Status ≥ 70%
Key exclusion criteria (5 listed)
- Mesothelioma and other tumors of the pleura
- Pregnant Women
- Allergic to iodine or intravenous contrast agent (applies only to patients with a pancreas or liver malignancy)
- Renal impairment due to the use of a contrast agent
- Patients with pacemakers and defibrillators
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 |
|---|---|---|
| respiration correlated CT scanThoracic malignancies (study group 1): Patients to be treated for gastro-esophageal junction (GEJ) malignancy undergo an implantation procedure of two or three radiopaque markers several days prior to treatment simulation, which are used to correct patient position at treatment. At treatment simulation, patients receive a standard CT scan followed by an RCCT scan. In cases of GEJ malignancy, oral contrast is administered prior to the standard CT scan; this is done at the treating physician's discretion. The standard CT is used to design the radiation treatment plan, where as the RCCT is used to define a volume that encompasses the motion extent of the tumor with breathing and is transferred to the standard CT. | Procedure or surgery | thoracic (study group 1) malignancies |
| respiration correlated CT scanAbdominal malignancies (study group 2): Patients undergo an implantation procedure of two or three radiopaque markers several days prior to treatment simulation. At treatment simulation, patients receive a standard CT scan followed by an RCCT scan. Intravenous contrast is administered prior to the standard CT; this is done at the treating physician's discretion. | Procedure or surgery | abdominal (study group 2) malignancies |
Primary outcome
To determine whether motion-corrected cone-beam CT (CBCT) improves the localization accuracy
Time frame: 2 years
of thoracic tumors (evaluated using study group 1) and organs-at-risk (evaluated using study group 2) relative to the standard cone-beam CT procedure.
To determine whether motion-corrected cone-beam CT (CBCT) can visualize and localize abdominal tumors using intravenous contrast enhancement.
Time frame: 2 years
(evaluated using study group 2).
2 secondary outcomes
To determine whether motion-corrected cone-beam CT (CBCT) derived from a respiration correlated CT (RCCT) scan on the same day improves localization accuracy
Time frame: 2 years
To determine whether tumor and organ-at-risk positions localized in cone-beam CT (CBCT)
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 6 Feb 2018.
- 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.
Gikas Mageras, PhD 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 respiration correlated CT scan in people with Gastric Cancer and 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 5 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 6 Feb 2018. 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 determine whether motion-corrected cone-beam CT (CBCT) improves the localization accuracy (time frame: 2 years). The study lists 2 primary outcomes in all. 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 6 Feb 2018.