An interventional study of Ultrasound scan of the pancreas and Ultrasound scan of the Liver in Pancreatic Cancer and Liver Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Not applicable, Interventional, and Diagnostic
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.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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 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 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
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
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
Abdominal Soft-tissue Movement
Measuring changes in abdominal soft-tissue movement through 4D ultrasound system
Time frame: 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
Time frame: 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
Time frame: change in imaging studies of 4D ultrasound from baseline to 3 weeks
Change in Dosimetry Measurements
Evaluation of dosimetry differences due to target/organ motion observed
Time frame: dosimetric changes in abdominal soft-tissue movement from baseline to the end of radiation treatment at 3 weeks
| Milestone | Pancreatic Cancer | Liver Cancer | Healthy Volunteer |
|---|---|---|---|
| Started | 2 | 0 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 2 | 0 | 0 |
| Withdrew: Sponsor closed study after one month | 2 | 0 | 0 |
Measuring changes in abdominal soft-tissue movement through 4D ultrasound system
No measurements were reported for this outcome.
monitoring of tumor and surrounding organ/tissue during pancreas and liver SBRT treatments using 4D ultrasound system
No measurements were reported for this outcome.
Evaluate accuracy of the 4D ultrasound motion monitoring system compare to CBCT based intra-fraction motion monitoring during pancreas and liver SBRT treatments
No measurements were reported for this outcome.
Evaluation of dosimetry differences due to target/organ motion observed
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pancreatic Cancer | — | — | — |
| Liver Cancer | — | — | — |
| Healthy Volunteer | — | — | — |
Sponsor closed study after 2 patients in Pancreatic Cancer arm of the study were enrolled.
| Age, Continuous(years) | Pancreatic Cancer | Liver Cancer | Healthy Volunteer | Total |
|---|---|---|---|---|
| Mean | 76 (74 to 78) | — | — | 76 (74 to 78) |
| Sex: Female, Male(Participants) | Pancreatic Cancer | Liver Cancer | Healthy Volunteer | Total |
|---|---|---|---|---|
| Female | 1 | — | — | 1 |
| Male | 1 | — | — | 1 |
| Ethnicity (NIH/OMB)(Participants) | Pancreatic Cancer | Liver Cancer | Healthy Volunteer | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 0 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pancreatic Cancer | Liver Cancer | Healthy Volunteer | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 2 | 0 | 0 | 2 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins