Respiratory Tumor and Normal Tissue Motion
Assessing the Magnitude and Potential Impact of Respiration-Induced Three-Dimensional Motion of Tumors and Normal Tissues Using Four-Dimensional CT Technology
1 other identifier
observational
86
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 22, 2006
CompletedFirst Posted
Study publicly available on registry
December 25, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedOctober 23, 2012
October 1, 2012
7.9 years
December 22, 2006
October 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Indices of Respiration-induced Anatomic Structure Motion, Structure Volume + Structure Shape Changes
3 Years Data Collection: Up to 12 scanning sessions per patient from baseline to completion of radiotherapy (minimally 4 week treatment)
Study Arms (1)
Respiratory Tumor + Normal Tissue Motion
Interventions
A total of up to 12 scanning sessions used to understand how the tumor and other organs move while breathing.
Eligibility Criteria
Study participants with Abdominal or Lung Cancer.
You may qualify if:
- Patients with pathological diagnosis of cancer in the thorax or abdomen.
- Patients must be planned to have radiation therapy delivered over at least 4 weeks (a minimum standard duration of curative radiotherapy).
- Patients must be able to lie flat for the duration of the CT image acquisition sessions.
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James D. Cox, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2006
First Posted
December 25, 2006
Study Start
November 1, 2004
Primary Completion
October 1, 2012
Last Updated
October 23, 2012
Record last verified: 2012-10