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Assessment of the Reliability of Implanted Fiducials for Tracking of Respiratory-Induced Tumor Motion

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Trial Information

Assessment of the Reliability of Implanted Fiducials for Tracking of Respiratory-Induced Tumor Motion

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.

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Baseline, 6 weeks

Safety Issue:


Principal Investigator

George Starkschall, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2004

Completion Date:

December 2011

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • Respiratory-Induced Tumor Motion
  • Tumor Motion
  • Pulmonary Function
  • Fiducial Marker
  • Lung Neoplasms



UT MD Anderson Cancer CenterHouston, Texas  77030