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Ultrasound Monitoring of Abdominal Soft Tissue

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ClinicalTrials.gov Identifier: NCT02722616
Recruitment Status : Active, not recruiting
First Posted : March 30, 2016
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:

This research study is being done to collect data and analyze the motion of soft tissue in the abdomen (liver, pancreas, stomach and intestines) of people who have pancreatic and liver cancer as well as healthy volunteers.

During the study researchers will look at the movement of organs in the abdomen that naturally occurs with breathing and with a bowel movement.

This study will examine the differences between abdominal soft tissue motion in healthy volunteers and in cancer patients with the goal of developing a better way to manage and minimize the abdominal soft tissue motion. Accurate location of the tumor is very important in treatment delivery and reduction of toxicity.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Liver Cancer Device: Ultrasound scan of the pancreas Device: Ultrasound scan of the Liver Drug: Reference ultrasound Not Applicable

Detailed Description:

Within the last decade, Linac based stereotactic body radiation therapy (SBRT) has been shown to be an effective treatment option for pancreas1, 2 and liver3, 4 tumors. SBRT delivers high doses of radiation therapy to the tumor over only 1-5 treatments. Because of the spatial precision of SBRT, it is feasible to administer a high radiation dose in only a few treatments. By minimizing the amount of radiation to surrounding healthy tissue, it is possible to decrease the rate of toxicity/complication and increase the radiation dose to cancerous tissue, thereby allowing better local control.

SBRT of the abdomen has been limited by the movement of intra-abdominal organs that naturally occurs with respiration and bowel movement. Organ motion occurs both intra- and inter-fractionally. While intra-fractional motion is a result of respiration, peristalsis and cardiac motion, the magnitude of inter-fractional target motion is dependent of daily variations in organ filling, weight change, tumor growth and radiation induced changes of tissue. Tumor movement may lead to tumor displacement and suboptimal dose delivery. Accurate localization of the target is very important to improve treatment delivery accuracy and reduce toxicity of the treatment. To evaluate tumor motion due to breathing motion, a 4-D CT simulation scan is performed. If the tumor moves more than 3 mm during a breathing cycle, breathing motion management is employed using Active Breathing Control (ABC) technique. ABC requires the patient to hold his/her breath within the proper tidal volume while treatment is delivered, while free breathing may be resumed between periods of treatment. This technique limits the delivery of RT to specific phases of the respiratory cycle so as to minimize the influence of breathing on the delineated tumor.

Despite significant progress made in ABC technique, tumor and organ motion could only be minimized and not eliminated completely with this technique. Assessing patient specific tumor/organ motion (both intra- and interfractional) throughout the course of SBRT treatment offers the possibility of ensuring delivery of the prescribed target dose while simultaneously minimizing normal tissue damage. In order to monitor the abdominal soft tissue motion, the Department of Radiation Oncology has developed a 4D ultrasound technique based on an ultrasound probe holder and a continuous motion monitoring software. The 4D ultrasound image is acquired by using a motorized 3D ultrasound probe and image continuously. 4D ultrasound is a new non-ionizing and non-invasive imaging technique that continuously monitors the tumor motion during the radiation treatment in real time.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ultrasound System For Non-Invasive, Real-Time Monitoring of Abdominal Soft Tissue
Actual Study Start Date : May 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pancreatic Cancer

A 4D ultrasound scan of the pancreas will be acquired at the time at simulation and used as a reference ultrasound image for localizing tracking target. The ultrasound probe will be placed at the abdominal area to monitor the pancreas motion. The probe will remain in place during the CT scan. Patient setup and the ultrasound probe location will be recorded so that the same setup can be reproduced during treatment delivery. The ultrasound probe in the CT image will be contoured and radiation beams that directly pass through the ultrasound probe will be avoided.

On each treatment day, 4D ultrasound images will be acquired continuously during beam on time to monitor pancreas motion. Intra-fraction CBCT images acquired during treatment will be registered with reference CT images. Organ motion registered by ultrasound will be compared to motion recorded by CBCT and the accuracy of the ultrasound system will be evaluated.

Device: Ultrasound scan of the pancreas
A 4D ultrasound scan will be acquired at the time at simulation and used as a reference ultrasound image for localizing tracking target. The ultrasound probe will be placed at the abdominal area to monitor the pancreas motion. The probe will remain in place during the CT scan. Patient setup and the ultrasound probe location will be recorded so that the same setup can be reproduced during treatment delivery.
Other Name: 4D ultrasound

Active Comparator: Liver Cancer

A 4D ultrasound scan of the liver will be acquired at the time at simulation and used as a reference ultrasound image for localizing tracking target. The ultrasound probe will be placed at the abdominal area to monitor the liver motion. The probe will remain in place during the CT scan. Patient setup and the ultrasound probe location will be recorded so that the same setup could be reproduced during treatment delivery.

On each treatment day, 4D ultrasound images will be acquired continuously during beam on time to monitor liver motion. The system will record all relevant images, but will not be used in clinical decision making. Intra-fraction CBCT images acquired during treatment will be registered with reference CT images. Organ motion registered by ultrasound will be compared to motion recorded by CBCT and the accuracy of the ultrasound system will be evaluated.

Device: Ultrasound scan of the Liver
A 4D ultrasound scan will be acquired at the time at simulation and used as a reference ultrasound image for localizing tracking target. The ultrasound probe will be placed at the abdominal area to monitor the liver motion. The probe will remain in place during the CT scan. Patient setup and the ultrasound probe location will be recorded so that the same setup could be reproduced during treatment delivery. The ultrasound probe in the CT image will be contoured and radiation beams that directly pass through the ultrasound probe will be avoided.
Other Name: 4D ultrasound

Healthy Volunteer
A reference ultrasound scan will be conducted on each subject during breath-hold. Subjects will be required to lie in supine position and engaged with ABC; an ultrasound probe will be placed at the abdomen area with minimal pressure applied. Continuous motion monitoring is achieved by acquiring 4D ultrasound images using a motorized 3D ultrasound probe to image the pancreas, liver and other intra-abdominal organs continuously. Several 4D ultrasound scans will be collected during subsequent breath-holds that serve as secondary images. Additional registration of ultrasound images will be performed with Velocity software to evaluate accuracy of automated registration software in the ultrasound system.
Drug: Reference ultrasound
A reference ultrasound scan will be conducted on each subject during breath-hold. Subjects will be required to lie in supine position and engaged with ABC; an ultrasound probe will be placed at the abdomen area with minimal pressure applied. Continuous motion monitoring is achieved by acquiring 4D ultrasound images using a motorized 3D ultrasound probe to image the pancreas, liver and other intra-abdominal organs continuously. Several 4D ultrasound scans will be collected during subsequent breath-holds that serve as secondary images.
Other Name: 4D ultrasound




Primary Outcome Measures :
  1. Abdominal soft-tissue movement [ Time Frame: change in abdominal soft-tissue movement from baseline to 3 weeks ]
    Measuring changes in abdominal soft-tissue movement through 4D ultrasound system

  2. Tissue change during radiation treatment [ Time Frame: change in tumor tissue from baseline to 3 weeks ]
    monitoring of tumor and surrounding organ/tissue during pancreas and liver SBRT treatments using 4D ultrasound system

  3. Change 4D ultrasound to traditional CBCT monitoring [ Time Frame: change in imaging studies of 4D ultrasound from baseline to 3 weeks ]
    Evaluate accuracy of the 4D ultrasound motion monitoring system compare to CBCT based intra-fraction motion monitoring during pancreas and liver SBRT treatments


Secondary Outcome Measures :
  1. Change in dosimetry measurements [ Time Frame: dosimetric changes in abdominal soft-tissue movement from baseline to the end of radiation treatment at 3 weeks ]
    Evaluation of dosimetry differences due to target/organ motion observed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Arm 1: Healthy adult (age >18 years)
  • Arm 2: Pancreatic cancer patients (age >18 years) currently receive SBRT treatment at JHU
  • Arm 3: Hepatic cancer patients (age >18 years) currently receive SBRT treatment at JHU

Exclusion Criteria:

  • Children (age < 18 years) are excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722616


Locations
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United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Amol Narang, M.D. The SKCCC at Johns Hopkins

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02722616     History of Changes
Other Study ID Numbers: J14176
IRB00053627 ( Other Identifier: JHMIRB )
R01CA161613 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Ultrasound

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases
Liver Extracts
Pancrelipase
Pancreatin
Hematinics
Gastrointestinal Agents