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

Primary Purpose

Gastric Cancer, Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

respiration correlated CT scan

About this trial

This is an interventional diagnostic trial for Gastric Cancer focused on measuring gastro-esophageal junction, lung, abdominal, cone-beam CT (CBCT), 10-146

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

thoracic (study group 1) malignancies

abdominal (study group 2) malignancies

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

To determine whether motion-corrected cone-beam CT (CBCT) can visualize and localize abdominal tumors using intravenous contrast enhancement.

(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

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)

prior to treatment remain constant throughout the treatment fraction.

Full Information

NCT ID

NCT01213004

First Posted

September 29, 2010

Last Updated

February 2, 2018

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

University of North Carolina, Chapel Hill, Varian Medical Systems

1. Study Identification

Unique Protocol Identification Number

NCT01213004

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

February 2018 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

University of North Carolina, Chapel Hill, Varian Medical Systems

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer, Lung Cancer

Keywords

gastro-esophageal junction, lung, abdominal, cone-beam CT (CBCT), 10-146

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

thoracic (study group 1) malignancies

Arm Type

Experimental

Arm Description

Arm Title

abdominal (study group 2) malignancies

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

respiration correlated CT scan

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

respiration correlated CT scan

Intervention Description

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.

Primary Outcome Measure Information:

Title

To determine whether motion-corrected cone-beam CT (CBCT) improves the localization accuracy

Description

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.

Time Frame

2 years

Title

To determine whether motion-corrected cone-beam CT (CBCT) can visualize and localize abdominal tumors using intravenous contrast enhancement.

Description

(evaluated using study group 2).

Time Frame

2 years

Secondary Outcome Measure Information:

Title

To determine whether motion-corrected cone-beam CT (CBCT) derived from a respiration correlated CT (RCCT) scan on the same day improves localization accuracy

Description

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.

Time Frame

2 years

Title

To determine whether tumor and organ-at-risk positions localized in cone-beam CT (CBCT)

Description

prior to treatment remain constant throughout the treatment fraction.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gikas Mageras, PhD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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