Lung CancerNCT00500513
Tracking of Respiratory-Induced Tumor Motion Using Implanted Fiducials
A study testing CT Scans, Implanted markers and Radiation Treatment (RT) in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: To determine the safety of fiducial implantation. To determine the extent/rate of migration of radio-opaque fiducials placed in lung tumors and adjacent normal tissue. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- CT Scans, Implanted markers and Radiation Treatment (RT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Dec 2011
- Phase
- Interventional
- 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
Who may be able to join
- Patient must be undergoing radiation treatment.
- Planned course of radiation treatment must be greater than or equal to 6 weeks.
- The patient is able to tolerate bronchoscopy: a. Able to maintain oxygen saturation >95% on room air nasal cannula supplementation <5L/min, b. Can tolerate supine position without respiratory difficulties, c. Has normal hemodynamic parameters, d. Has normal coagulation profile
- The patient is a candidate for bronchogenic placement of seeds.
- The patient has an identifiable tumor on a CT scan.
- The patient has signed the consent form.
Who cannot join
- The patient has had previous thoracic surgery (e.g., lobectomy, pneumonectomy, tumor excision). Biopsy, mediastinoscopy, mastectomy are not exclusions.
- The patient has had previous radiation to the thorax.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Reliability of Implanted Fiducials for Tracking of Respiratory-Induced Tumor Motion
Objectives:
- To determine the safety of fiducial implantation.
- To determine the extent/rate of migration of radio-opaque fiducials placed in lung tumors and adjacent normal tissue.
- To compare real-time portal imaging-based fiducial tracking with measurement of three-dimensional motion by four-dimensional CT scanning to determine how many fiducials are needed to track a tumor.
- To determine if intra-fractional lung tumor motion changes during a course of treatment, and when during the treatment this occurs.
- To correlate the position of internal fiducials with the position of the external patient surface during respiration.
- To quantify the residual motion of the clinical target volume during radiotherapy gated using external fiducials.
- To verify the adequacy of the treatment portal margins in encompassing the residual motion of the clinical target volume.
- To determine if radio-opaque fiducial placement adjacent to the trachea (which does not move) can reduce daily setup inaccuracies, and so spare normal tissue.
- To determine the motion of hilar adenopathy (if any), and whether it correlates with motion of the primary tumor.
Read the detailed description
If you are eligible to take part in this study, you will have pulmonary (lung) function testing. This testing will involve your breathing through a mouthpiece and measuring the amount of air you breathe. This will provide information on how well your lungs work, and how your chest wall moves when you breathe.
You will then begin the normal treatment planning process. A bean-bag "cast" will be made for you to lie in during planning and treatment. This is done to lower day-to-day changes in your position. A CT scan will be taken with you breathing quietly, and possibly several X-rays will be performed as well. You will be marked with magic marker, and possibly have several permanent tattoos placed to help with daily positioning. These procedures normally take 1-2 hours.
Small metal markers (up to 5) will then be placed near your tumor. A thin, flexible tube with a camera, called a bronchoscope, will be used to place these markers in your lungs. You will be given a sedative through one of your veins and a local anesthetic will be sprayed in your nose and mouth before introducing the bronchoscope. The bronchoscope is introduced through one of your nostrils and then passed into your windpipe and bronchial tubes. This will allow the doctor to examine your lungs and place the small metal markers. These markers will be used to track the tumor during treatment. In this way the radiation treatment can be given to the tumor even if it moves while you breathe.
You will also have studies to measure how much the tumor moves. This will be done with several additional CT scans, typically taken on a weekly basis. Additional pulmonary function measurements will be taken during the CT scans. These measurements will allow researchers to monitor the movement of your tumor when you breathe. These procedures will normally take between 1 and 2 hours.
You will be on this study for the duration of your radiation treatments. You will be followed up an for an additional 4 - 6 weeks to make sure there are no complications from the study.
THIS IS AN INVESTIGATIONAL STUDY. A total of up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Lung Cancer
- Being tested
- CT Scans, Implanted markers, Radiation Treatment (RT)
- Keywords
- Lung Cancer, Respiratory-Induced Tumor Motion, Tumor Motion, Pulmonary Function, Fiducial Marker
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT ScansProcedure or surgery
Also called Computed Tomography, 4-D CT Scan
CT scan performed weekly to measure how much the tumor moves + additional pulmonary function measurements.
Implanted markersProcedure or surgery
Implanted radio-opaque fiducial markers, diameter of 1.0 - 2.0 mm, inserted through a catheter at several chest locations using a flexible bronchoscope
Radiation Treatment (RT)Radiation
Also called RT, XRT
Radiotherapy incorporating respiratory treatment delivery
| Study group | Role | What they receive |
|---|---|---|
| Implanted Markers + CT + RT | Experimental | Not described Receives: Procedure: CT Scans; Procedure: Implanted markers; Radiation: Radiation Treatment (RT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients experiencing motion of one or more fiducials during the course of radiation therapy
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startApr 2004
- Primary completionJun 2007
- Study completionDec 2011
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Starkschall, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500513
- Sponsor's protocol ID
- ID03-0208
- Status last verified
- Jan 2013
- First submitted
- 10 Jul 2007
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Reliability of Implanted Fiducials for Tracking of Respiratory-Induced Tumor Motion
- ClinicalTrials.gov ID
- NCT00500513
- Acronym / sponsor ID
- ID03-0208
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Respiratory-Induced Tumor Motion, Tumor Motion, Pulmonary Function, Fiducial Marker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Jul 2007 (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.
Objectives:
- To determine the safety of fiducial implantation.
- To determine the extent/rate of migration of radio-opaque fiducials placed in lung tumors and adjacent normal tissue.
- To compare real-time portal imaging-based fiducial tracking with measurement of three-dimensional motion by four-dimensional CT scanning to determine how many fiducials are needed to track a tumor.
- To determine if intra-fractional lung tumor motion changes during a course of treatment, and when during the treatment this occurs.
- To correlate the position of internal fiducials with the position of the external patient surface during respiration.
- To quantify the residual motion of the clinical target volume during radiotherapy gated using external fiducials.
- To verify the adequacy of the treatment portal margins in encompassing the residual motion of the clinical target volume.
- To determine if radio-opaque fiducial placement adjacent to the trachea (which does not move) can reduce daily setup inaccuracies, and so spare normal tissue.
- To determine the motion of hilar adenopathy (if any), and whether it correlates with motion of the primary tumor.
Detailed description
If you are eligible to take part in this study, you will have pulmonary (lung) function testing. This testing will involve your breathing through a mouthpiece and measuring the amount of air you breathe. This will provide information on how well your lungs work, and how your chest wall moves when you breathe.
You will then begin the normal treatment planning process. A bean-bag "cast" will be made for you to lie in during planning and treatment. This is done to lower day-to-day changes in your position. A CT scan will be taken with you breathing quietly, and possibly several X-rays will be performed as well. You will be marked with magic marker, and possibly have several permanent tattoos placed to help with daily positioning. These procedures normally take 1-2 hours.
Small metal markers (up to 5) will then be placed near your tumor. A thin, flexible tube with a camera, called a bronchoscope, will be used to place these markers in your lungs. You will be given a sedative through one of your veins and a local anesthetic will be sprayed in your nose and mouth before introducing the bronchoscope. The bronchoscope is introduced through one of your nostrils and then passed into your windpipe and bronchial tubes. This will allow the doctor to examine your lungs and place the small metal markers. These markers will be used to track the tumor during treatment. In this way the radiation treatment can be given to the tumor even if it moves while you breathe.
You will also have studies to measure how much the tumor moves. This will be done with several additional CT scans, typically taken on a weekly basis. Additional pulmonary function measurements will be taken during the CT scans. These measurements will allow researchers to monitor the movement of your tumor when you breathe. These procedures will normally take between 1 and 2 hours.
You will be on this study for the duration of your radiation treatments. You will be followed up an for an additional 4 - 6 weeks to make sure there are no complications from the study.
THIS IS AN INVESTIGATIONAL STUDY. A total of up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted Markers + CT + RT | Experimental | Procedure: CT Scans, Procedure: Implanted markers, Radiation: Radiation Treatment (RT) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patient must be undergoing radiation treatment.
- Planned course of radiation treatment must be greater than or equal to 6 weeks.
- The patient is able to tolerate bronchoscopy: a. Able to maintain oxygen saturation >95% on room air nasal cannula supplementation <5L/min, b. Can tolerate supine position without respiratory difficulties, c. Has normal hemodynamic parameters, d. Has normal coagulation profile
- The patient is a candidate for bronchogenic placement of seeds.
- The patient has an identifiable tumor on a CT scan.
Key exclusion criteria (2 listed)
- The patient has had previous thoracic surgery (e.g., lobectomy, pneumonectomy, tumor excision). Biopsy, mediastinoscopy, mastectomy are not exclusions.
- The patient has had previous radiation to the thorax.
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 |
|---|---|---|
| CT ScansAlso: Computed Tomography, 4-D CT ScanCT scan performed weekly to measure how much the tumor moves + additional pulmonary function measurements. | Procedure or surgery | Implanted Markers + CT + RT |
| Implanted markersImplanted radio-opaque fiducial markers, diameter of 1.0 - 2.0 mm, inserted through a catheter at several chest locations using a flexible bronchoscope | Procedure or surgery | Implanted Markers + CT + RT |
| Radiation Treatment (RT)Also: RT, XRTRadiotherapy incorporating respiratory treatment delivery | Radiation | Implanted Markers + CT + RT |
Primary outcome
Number of patients experiencing motion of one or more fiducials during the course of radiation therapy
Time frame: Baseline, 6 weeks
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 1 Feb 2013.
- 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.
George Starkschall, PhD 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?
A study testing CT Scans, Implanted markers and Radiation Treatment (RT) in people with Lung 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 6 inclusion and 2 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 1 Feb 2013. 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?
Number of patients experiencing motion of one or more fiducials during the course of radiation therapy (time frame: Baseline, 6 weeks). 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 1 Feb 2013.