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Completed

NCT Number: NCT01213004

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

respiration correlated CT scan

Procedure

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.

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • University of North Carolina, Chapel Hill
  • Varian Medical Systems

Registry information

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Oct 1, 2010
Registry last updated
Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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