Evaluation of Respiratory Motion-Corrected Cone-Beam CT in Radiation Treatment of Thoracic and Abdominal Cancers

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT01213004

Collaborator

University of North Carolina, Chapel Hill (Other), Varian Medical Systems (Industry)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Lung Cancer	Procedure: respiration correlated CT scan Procedure: respiration correlated CT scan	N/A

Study Design

Study Type:

Interventional

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 :

Sep 1, 2010

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

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.	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.
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.

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.

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.

Experimental: abdominal (study group 2) malignancies

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.

Outcome Measures

Primary Outcome Measures

To determine whether motion-corrected cone-beam CT (CBCT) improves the localization accuracy [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. [2 years]
(evaluated using study group 2).

Secondary Outcome Measures

To determine whether motion-corrected cone-beam CT (CBCT) derived from a respiration correlated CT (RCCT) scan on the same day improves localization accuracy [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) [2 years]
prior to treatment remain constant throughout the treatment fraction.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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