Trial Outcomes & Findings for Ultrasound Monitoring of Abdominal Soft Tissue (NCT NCT02722616)

NCT ID: NCT02722616

Last Updated: 2024-01-18

Results Overview

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

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

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

Results posted on

2024-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.	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. 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.	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. 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.
Overall Study STARTED	2	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.	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. 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.	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. 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.
Overall Study Sponsor closed study after one month	2	0	0

Baseline Characteristics

Ultrasound Monitoring of Abdominal Soft Tissue

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pancreatic Cancer n=2 Participants 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. 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.	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. 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.	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. 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.	Total n=2 Participants Total of all reporting groups
Race (NIH/OMB) White	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Age, Continuous	76 years n=5 Participants	—	—	76 years n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	—	1 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	—	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

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

Population: Patients were consented, enrolled and taken off study during the period 5/3/2016-6/9/2016. Data was not collected or analyzed because the sponsor closed the study early. In order to collect and analyze the data, treatment would have to have been completed.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

Pancreatic Cancer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Liver Cancer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Volunteer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amol Narang

Johns Hopkins, East Baltimore

Phone: 410-913-3395

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place