Evaluation of Respiratory Motion-Corrected Cone-Beam CT in Radiation Treatment of Thoracic and Abdominal Cancers
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ClinicalTrials.gov Identifier: NCT01213004 |
Recruitment Status
:
Completed
First Posted
: October 1, 2010
Last Update Posted
: February 6, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Cancer Lung Cancer | Procedure: respiration correlated CT scan | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 52 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Evaluation of Respiratory Motion-Corrected Cone-Beam CT in Radiation Treatment of Thoracic and Abdominal Cancers |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | February 2018 |
Actual Study Completion Date : | February 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: thoracic (study group 1) malignancies
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.
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Procedure: respiration correlated CT scan
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.
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Experimental: abdominal (study group 2) malignancies
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.
|
Procedure: respiration correlated CT scan
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.
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- 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).
- 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 ]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.
- To determine whether tumor and organ-at-risk positions localized in cone-beam CT (CBCT) [ Time Frame: 2 years ]prior to treatment remain constant throughout the treatment fraction.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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%
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213004
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Gikas Mageras, PhD | Memorial Sloan Kettering Cancer Center |
Additional Information:
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT01213004 History of Changes |
Other Study ID Numbers: |
10-146 |
First Posted: | October 1, 2010 Key Record Dates |
Last Update Posted: | February 6, 2018 |
Last Verified: | February 2018 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
gastro-esophageal junction lung abdominal cone-beam CT (CBCT) 10-146 |
Additional relevant MeSH terms:
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |