Ultrasound Monitoring of Abdominal Soft Tissue

NCT02722616 | Terminated Results DMC

• 3 other identifiers: J14176IRB00053627R01CA161613
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Liver Cancer

Keywords

Ultrasound

Outcome Measures

Primary Outcomes (3)

• Abdominal Soft-tissue Movement

  Measuring changes in abdominal soft-tissue movement through 4D ultrasound system

  change in abdominal soft-tissue movement from baseline to 3 weeks

• Tissue Change During Radiation Treatment

  monitoring of tumor and surrounding organ/tissue during pancreas and liver SBRT treatments using 4D ultrasound system

  change in tumor tissue from baseline to 3 weeks

• Change 4D Ultrasound to Traditional Cone-beam Computed Tomography (CBCT) Monitoring

  Evaluate accuracy of the 4D ultrasound motion monitoring system compare to CBCT based intra-fraction motion monitoring during pancreas and liver SBRT treatments

  change in imaging studies of 4D ultrasound from baseline to 3 weeks

Secondary Outcomes (1)

• Change in Dosimetry Measurements

  dosimetric changes in abdominal soft-tissue movement from baseline to the end of radiation treatment at 3 weeks

Study Arms (3)

Pancreatic Cancer

ACTIVE COMPARATOR

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

Liver Cancer

ACTIVE COMPARATOR

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

Healthy Volunteer

OTHER

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

Interventions

Ultrasound scan of the pancreas DEVICE

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.

Also known as: 4D ultrasound

Pancreatic Cancer

Ultrasound scan of the Liver DEVICE

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.

Also known as: 4D ultrasound

Liver Cancer

Reference ultrasound DRUG

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.

Also known as: 4D ultrasound

Healthy Volunteer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Children (age \< 18 years) are excluded.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases

Results Point of Contact

• Title: Dr. Amol Narang
• Organization: Johns Hopkins, East Baltimore

anarang2@jhmi.edu

410-913-3395

Study Officials

• Amol Narang, M.D.

  The SKCCC at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: March 30, 2016
• Study Start: May 1, 2016
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: January 18, 2024
• Results First Posted: January 18, 2024

Record last verified: 2023-12

Locations

US (1)