Respiratory Tumor and Normal Tissue Motion

October 22, 2012 updated by: M.D. Anderson Cancer Center

Assessing the Magnitude and Potential Impact of Respiration-Induced Three-Dimensional Motion of Tumors and Normal Tissues Using Four-Dimensional CT Technology

Primary Objectives:

  • To collect accurate and reliable respiration-induced anatomic structure motion data using four-dimensional (4-D) imaging technology.
  • To analyze these data to study respiration-induced variations and patterns in variations of positions, shapes and volumes of tumors and normal anatomic structures in the thorax and abdomen over a breathing cycle, from one breathing cycle to the next, day-to-day and over the course of radiotherapy.
  • To assess dosimetric and potential clinical consequences of respiratory motion in the current practice of radiotherapy through preclinical treatment simulation (treatment planning) studies.
  • To quantify the potential consequences of explicitly accounting for respiration-induced motion on dose distributions and outcome (tumor control probabilities and normal tissue complication probabilities) through preclinical treatment simulation studies.

Secondary Objectives:

  • To investigate the feasibility of using patient training to regulate patient breathing and improve the quality of images and to stratify patients for their eligibility for respiratory-correlated imaging and radiotherapy and for the implementation of various strategies for mitigation of respiratory-induced motion.
  • To assess the degree of correlation of the marker (or internal anatomic structure such as diaphragm) being tracked as surrogate of breathing with the motion of structures and the intra-fraction and inter-fraction reproducibility of such correlation.
  • To quantify the effects of radiation therapy on the patterns of respiratory-induced motion of structures through preclinical treatment simulation studies.
  • To compare various strategies for either accounting for or mitigating respiration-induced motion in the planning and delivery of radiation therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

You will be taking part in this study while you receive radiotherapy treatment for your tumor.

You will be trained to breathe in a certain way that will help the study staff to perform motion CT scans. You may be asked to breathe normally, or hold your breath, or breathe while following a TV monitor. On the monitor, you will be viewing your breathing trace and using the trace to regulate your breathing as instructed by the health professionals.

While you are in the right position for the scan, the study staff will perform motion CT scans. A total of up to 12 scanning sessions will be held over your entire course of radiotherapy. The first scanning session may last from 45 to 90 minutes, but later sessions may be shorter. These CT scans are separate from the routine CT scans you may receive as part of regular radiation treatment planning.

Scans may be taken at various periods of time. The scans can be taken one right after another, or with a short separation between them. One scan can be taken on the first day, and the next scan on the next day, or up to a week later.

By looking at the scans, researchers can better understand how your tumor and other organs move from breath to breath, from day to day, and from week to week.

This is an investigational study. About 210 patients with the same tumor location as you will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Observational

Enrollment (Actual)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study participants with Abdominal or Lung Cancer.

Description

Inclusion Criteria:

  1. Patients with pathological diagnosis of cancer in the thorax or abdomen.
  2. Patients must be planned to have radiation therapy delivered over at least 4 weeks (a minimum standard duration of curative radiotherapy).
  3. Patients must be able to lie flat for the duration of the CT image acquisition sessions.

Exclusion Criteria:

1. Patients who are neither able to breathe nor hold breath in a regular and reproducible manner will be removed from the study as being ineligible. Breathing or breath-holding regularity determination will be based on respiration traces acquired with the RPM system.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Respiratory Tumor + Normal Tissue Motion
Procedure: Motion CT Scans
A total of up to 12 scanning sessions used to understand how the tumor and other organs move while breathing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Indices of Respiration-induced Anatomic Structure Motion, Structure Volume + Structure Shape Changes
Time Frame: 3 Years Data Collection: Up to 12 scanning sessions per patient from baseline to completion of radiotherapy (minimally 4 week treatment)
3 Years Data Collection: Up to 12 scanning sessions per patient from baseline to completion of radiotherapy (minimally 4 week treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: James D. Cox, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 22, 2006

First Submitted That Met QC Criteria

December 22, 2006

First Posted (Estimate)

December 25, 2006

Study Record Updates

Last Update Posted (Estimate)

October 23, 2012

Last Update Submitted That Met QC Criteria

October 22, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-0962

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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