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Tracking of Respiratory-Induced Tumor Motion Using Implanted Fiducials

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT Scans
Implanted markers
Radiation Treatment (RT)
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung Cancer, Respiratory-Induced Tumor Motion, Tumor Motion, Pulmonary Function, Fiducial Marker

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient must be undergoing radiation treatment.
  2. Planned course of radiation treatment must be greater than or equal to 6 weeks.
  3. 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
  4. The patient is a candidate for bronchogenic placement of seeds.
  5. The patient has an identifiable tumor on a CT scan.
  6. The patient has signed the consent form.

Exclusion Criteria:

  1. The patient has had previous thoracic surgery (e.g., lobectomy, pneumonectomy, tumor excision). Biopsy, mediastinoscopy, mastectomy are not exclusions.
  2. The patient has had previous radiation to the thorax.

Sites / Locations

  • UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implanted Markers + CT + RT

Arm Description

Outcomes

Primary Outcome Measures

Number of patients experiencing motion of one or more fiducials during the course of radiation therapy

Secondary Outcome Measures

Full Information

First Posted
July 10, 2007
Last Updated
January 30, 2013
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00500513
Brief Title
Tracking of Respiratory-Induced Tumor Motion Using Implanted Fiducials
Official Title
Assessment of the Reliability of Implanted Fiducials for Tracking of Respiratory-Induced Tumor Motion
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer, Respiratory-Induced Tumor Motion, Tumor Motion, Pulmonary Function, Fiducial Marker

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implanted Markers + CT + RT
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
CT Scans
Other Intervention Name(s)
Computed Tomography, 4-D CT Scan
Intervention Description
CT scan performed weekly to measure how much the tumor moves + additional pulmonary function measurements.
Intervention Type
Procedure
Intervention Name(s)
Implanted markers
Intervention Description
Implanted radio-opaque fiducial markers, diameter of 1.0 - 2.0 mm, inserted through a catheter at several chest locations using a flexible bronchoscope
Intervention Type
Radiation
Intervention Name(s)
Radiation Treatment (RT)
Other Intervention Name(s)
RT, XRT
Intervention Description
Radiotherapy incorporating respiratory treatment delivery
Primary Outcome Measure Information:
Title
Number of patients experiencing motion of one or more fiducials during the course of radiation therapy
Time Frame
Baseline, 6 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Starkschall, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center

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Tracking of Respiratory-Induced Tumor Motion Using Implanted Fiducials

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