Lung CancerNCT00415675
Respiratory Tumor and Normal Tissue Motion
An observational study of Lung Cancer and Abdominal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer, Abdominal Cancer
- What is being tested?
- Motion CT Scans
- Type of treatment
- Surgery or procedure
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study participants with Abdominal or Lung Cancer.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Lung Cancer, Abdominal Cancer
- Being tested
- Motion CT Scans
- Keywords
- Lung Cancer, Abdominal Cancer, Tissue Motion, Breathing, Motion CT Scans
- Medical subject headings
- Lung Neoplasms, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion CT ScansProcedure or surgery
A total of up to 12 scanning sessions used to understand how the tumor and other organs move while breathing.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Tumor + Normal Tissue Motion | Not described Receives: Procedure: Motion CT Scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indices of Respiration-induced Anatomic Structure Motion, Structure Volume + Structure Shape Changes
Measured: 3 Years Data Collection: Up to 12 scanning sessions per patient from baseline to completion of radiotherapy (minimally 4 week treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2006 (estimated)
- Study startNov 2004
- Primary completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James D. Cox, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415675
- Sponsor's protocol ID
- 2003-0962
- Status last verified
- Oct 2012
- First submitted
- 22 Dec 2006
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Magnitude and Potential Impact of Respiration-Induced Three-Dimensional Motion of Tumors and Normal Tissues Using Four-Dimensional CT Technology
- ClinicalTrials.gov ID
- NCT00415675
- Acronym / sponsor ID
- 2003-0962
- Conditions
- Lung Cancer, Abdominal Cancer
- Keywords
- Lung Cancer, Abdominal Cancer, Tissue Motion, Breathing, Motion CT Scans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Oct 2012 (actual)
- First posted
- 25 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory Tumor + Normal Tissue Motion | – | Procedure: Motion CT Scans |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants with Abdominal or Lung Cancer.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motion CT ScansA total of up to 12 scanning sessions used to understand how the tumor and other organs move while breathing. | Procedure or surgery | Respiratory Tumor + Normal Tissue Motion |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James D. Cox, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Abdominal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2012.