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Ultrasound Monitoring of Abdominal Soft Tissue


2016-05


2022-10-28


2022-10-28


2

Study Overview

Ultrasound Monitoring of Abdominal Soft Tissue

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.

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 four dimensional (4D) 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.

  • Pancreatic Cancer
  • Liver Cancer
  • DEVICE: Ultrasound scan of the pancreas
  • DEVICE: Ultrasound scan of the Liver
  • DRUG: Reference ultrasound
  • J14176
  • IRB00053627 (OTHER Identifier) (OTHER: JHMIRB)
  • R01CA161613 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2015-04-15  

2023-11-01  

2023-12-22  

2016-03-23  

2023-12-22  

2024-01-18  

2016-03-30  

2024-01-18  

2023-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic


Allocation:
Non Randomized


Interventional Model:
Parallel


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/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 wi

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 pla
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 rem

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
OTHER: 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 mo

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 mo
Primary Outcome MeasuresMeasure DescriptionTime Frame
Abdominal Soft-tissue MovementMeasuring changes in abdominal soft-tissue movement through 4D ultrasound systemchange in abdominal soft-tissue movement from baseline to 3 weeks
Tissue Change During Radiation Treatmentmonitoring of tumor and surrounding organ/tissue during pancreas and liver SBRT treatments using 4D ultrasound systemchange in tumor tissue from baseline to 3 weeks
Change 4D Ultrasound to Traditional Cone-beam Computed Tomography (CBCT) MonitoringEvaluate accuracy of the 4D ultrasound motion monitoring system compare to CBCT based intra-fraction motion monitoring during pancreas and liver SBRT treatmentschange in imaging studies of 4D ultrasound from baseline to 3 weeks
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Change in Dosimetry MeasurementsEvaluation of dosimetry differences due to target/organ motion observeddosimetric changes in abdominal soft-tissue movement from baseline to the end of radiation treatment at 3 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

    Inclusion Criteria:

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

  • Exclusion Criteria:

  • Children (age < 18 years) are excluded.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • National Cancer Institute (NCI)

  • PRINCIPAL_INVESTIGATOR: Amol Narang, M.D., The SKCCC at Johns Hopkins

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available