Imaging Study Compare 4DCT Image

NCT01626001 | Completed Phase 1 DMC

• 2 other identifiers: 2011-06311dp20D007044-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn about ways to possibly reduce scanning errors when using 4-dimensional computed tomography (4D CT) scans to check lung function in patients with esophageal or lung cancer.

Conditions

Esophagus Cancer; Lung Cancer

Keywords

Esophagus Cancer; Lung Cancer; 4-dimensional computed tomography; 4D CT

Outcome Measures

Primary Outcomes (1)

• Patient Percentage with 4DCT Acquisition Artifacts

  Primary statistical analysis is intra-subject comparison of artifacts versus acquisition methods. In cohort 1: 4DCT acquisition techniques consist of 1) baseline acquisition, 2) extended acquisition, 3) real-time acquisition gating, and 4) re-imaging of bad segments. An automated computer scoring system, as described by Han et al., will be implemented and validated using the first 5 cases. To quantify 4DCT image quality, number and anatomic misplacement distance of artifacts will be measured, for each set of acquisition methods and each subject.

  1 day

Secondary Outcomes (1)

• Artifact Reproducibility Reducing 4DCT Acquisition

  1 day

Study Arms (2)

Cohort 1

EXPERIMENTAL

Cohort of 18 subjects evaluated. Subject will receive 4DCT cine acquisition gated using a respiratory signal from real-time position management (RPM) gating system. Maximum number of allowable images that may be acquired increased from 3000 to 5999 images. Total imaging time for each subject \< 60 minutes.

Procedure: 4D CT scans

Cohort 2

EXPERIMENTAL

Reproducibility of optimal 4DCT acquisition method determined from cohort 1 tested with cohort of 18 study subjects. Three 4DCT images acquired, all with acquisition method determined from cohort 1. Cohort also receives two spiral-mode 4DCT acquisitions.

Procedure: 4D CT scans

Interventions

4D CT scans PROCEDURE

4 (or 5 for Cohort 2) 4DCT scans performed. 1 scan performed while breath held for less than 20 seconds. CT scans take about 5 minutes each to complete.

Also known as: CT, X-ray, Computed Tomography

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must sign consent for the study.
• Patients with pathologic diagnosis of esophagus or lung cancer.
• Patient who plan to receive radiation therapy treatment at MD Anderson.
• Patient \>/=18 years of age

You may not qualify if:

• Presence of an implanted electronic device.
• Women who are pregnant or lactating, due to possible adverse effects on the developing fetus or infant.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Esophageal Neoplasms; Lung Neoplasms

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Thomas Guerrero, MD,PHD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 22, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 18, 2015

Record last verified: 2014-08

Locations

US (1)