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computed tomography scan of the chest under dep inspiration breath hold conditions

CT scan of the chest under deep inspiration breath hold

Don Yee, MD, FRCPC

Radiotherapy is a common treatment for lung cancer. One Challenge of delivering radiation treatment to lung tumors accurately is tumor movement which occurs as a patient breathes. In some situations, tumors move enough during breathing so that some or all of the tumor may be missed by a radiation treatment. One way to decrease the amount a lung tumor moves during radiotherapy treatments is for patients to held their breath briefly during a radiation treatment. By doing this, a patient's lung tumor may not move as much as it would during regular breathing. In this study, the investigators aim to study patients with lung cancers which move during breathing. Patients will be asked to hold their breath after inspiration while a CT scan of their lung tumor is obtained. The purpose of this study is to study how much less patients' lung tumors move when they hold their breath

Quantifying Lung Tumor Movement Under Deep Inspiration Breath Holds

Quantifying Lung Tumor Movement Under Dep Inspiration Breath Holds

Cross Cancer Institute

AHS Cancer Control Alberta

Skin and Connective Tissue Diseases

Breast Neoplasms

Abdominal Neoplasms

Breast Diseases

Skin Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Patients with \> 1 cm tumor motion simulated using 4DCT with and without CPAP

Patients with heart abutting chest wall will be simulated using 4DCT with and without CPAP

Patient with liver metastases for SBRT or pancreatic tumors will be simulated using 4DCT with and without CPAP

Continuous positive airway pressure (CPAP)

Zvi Symon, MD

Hila Genesin, MsC

Jeffrey Goldstein, MD

Yaacov R Lawrence, MD

This is a clinical study on patients to compare the effects of CPAP on lung volume diaphragm motion, heart position and tumor motion compared to free breathing. Only patients with significant tumor motion of greater than 1 cm amplitude or unfavorable chest wall geometry (heart close to chest wall) identified on standard imaging and simulation will be candidates for the study. Patients will be re- simulated and planned for radiation treatments with CPAP. The radiation plans generated with and without CPAP will be compared to evaluate the impact of CPAP on tumor motion and dose delivered to adjacent critical structures such as the heart and lung.

Primary Objectives

* Evaluate effectiveness of CPAP to reproducibly reduce tumor and organ motion during radiation therapy treatments.
* Determine if CPAP allows for a reduction in normal tissue receiving radiation in chest and abdomen tumors and reduce heart exposure for patients receiving left breast irradiation.

Entry Criteria: This is a proof of concept and feasibility study. We propose to study 10 patients in each group for a total of thirty patients.

Eligibility criteria Group1. Lung tumors and nodules with tumor motion greater than 1 cm on standard imaging (n=10) Group2. Left sided breast tumors with unfavorable anatomy, viz heart abutting chest wall (n=10) Group3. Upper abdominal tumors: Liver and Pancreas with tumor motion greater than 1 cm. (n=10)

Pretreatment evaluations/management for patients meeting eligibility criteria CPAP All patients will be evaluated by a pulmonologist for their respiratory performances including physical examination, oxygen saturation and pulmonary function tests including DLCO that will serve for baseline measures. Then, adjustment session will be performed aiming to get adjusted to a CPAP device till the maximal tolerated pressure is not more than 16 cmH20 (TBD) for 30 minutes.

All patients must be able to tolerate CPAP and comply with daily treatment. 4D CT: CT simulation is the basis of conformal treatment planning \[24, 25\]. By using a slow acquisition time of 3 minutes the motion effects due to breathing can be captured and a 4D image generated. The tumor position can be imaged throughout the breathing cycle and a Maximum Intensity Projection (MIP) can be constructed and used in treatment planning. If there is no tumor motion the size of the MIP would equal the tumor size. The MIP size will increase with increasing tumor motion. The planning software allows us to calculate the MIP dimensions and volume. In addition total lung volumes and change in diaphragm position can be calculated (Figure 1). Radiation therapy planning parameters and volumetric analysis of tumor and normal tissue motion and position are calculated using available software and transferred to the Eclipse treatment planning system \[17\].

Treatment Planning:

The Eclipse treatment planning system will be used to generate and compare plans for treatment with and without CPAP.

Details of Intervention

Simulation All treatment planning and CPAP evaluation will be done in the radiation therapy department. Patients will be simulated on the Phillips 4D big bore CT simulator. The 4D scan which is done slowly over several minutes allows us to assess the full range of tumor motion throughout the respiratory cycle. An ITV is calculated which includes the actual tumor size with an expansion to account for the range of motion of the tumor by accounting for tumor location throughout the respiratory cycle (MIP) The MIP is the basis for the ITV and is the structure used for treatment planning. Patients recruited for the study will be re-simulated with the patient in the same position while undergoing CPAP treatment. ITV size and volume will be calculated for the tumor in in both the standard and CPAP studies and used for planning.

RPM: Diaphragm motion and respiratory cycle information will be obtained using the RPM for both the standard and the CPAP simulations. Differences in the respiratory wave cycle will be recorded \[17\].

The MIP/ITV images will be transferred to the Eclipse treatment planning system and using both the standard breathing and CPAP simulations treatment plans will be generated. Standard radiation plan evaluation parameters will be used and plans compared with respect to tumor coverage and normal tissue and normal tissue in the radiation field.

Radiation Plan:

Identical field arrangements will be generated for CPAP and non CPAP plans. Plans will be evaluated using standard radiation therapy planning parameters including: MIP or ITV, total lung volume, volume of GTV/CTV/PTV/ V20 and MLD.

Pre treatment Compare standard conformal radiation plans using Eclipse treatment planning system for each patient with and without CPAP.

RPM tracings with and without CPAP will be compared for all groups pre- treatment.

Evaluation of Continuous Positive Airway Pressure for Tumor Motion Management in Radiotherapy

Evaluation of CPAP (Continuous Positive Airway Pressure) in the Planning of Radiation Treatments for Lung, Upper Abdomen and Left Breast Cancers

Measurement of the Internal Target Volume in cc

Mean Lung dose, Mean Heart dose measured in Gy

Sheba Medical Center

Chairman Radiation Oncology

CT scan performed weekly to measure how much the tumor moves + additional pulmonary function measurements.

CT Scans

Implanted radio-opaque fiducial markers, diameter of 1.0 - 2.0 mm, inserted through a catheter at several chest locations using a flexible bronchoscope

Implanted markers

Radiotherapy incorporating respiratory treatment delivery

Radiation Treatment (RT)

George Starkschall, PhD

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.

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quantifying Lung Tumor Movement Under Deep Inspiration Breath Holds	NCT00643370	Lung Cancer	CT scan of the ...	18 Years -	AHS Cancer Control Alberta
Evaluation of Continuous Positive Airway Pressure for Tumor Motion Management in Radiotherapy	NCT02324530	Tumor Motion "Continuous Pos... Lung Cancer Breast Cancer Abdominal Tumor...	Continuous posi...	18 Years -	Sheba Medical Center
Tracking of Respiratory-Induced Tumor Motion Using Implanted Fiducials	NCT00500513	Lung Cancer	CT Scans Implanted marke... Radiation Treat...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for tumor motion

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