Clinical trial NCT02722616: Ultrasound Monitoring of Abdominal Soft Tissue
Official title: Ultrasound System For Non-Invasive, Real-Time Monitoring of Abdominal Soft Tissue
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatic Cancer
Liver Cancer
Keywords: Ultrasound
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-03-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Abdominal Soft-tissue Movement
timeFrame: change in abdominal soft-tissue movement from baseline to 3 weeks
measure: Tissue Change During Radiation Treatment
timeFrame: change in tumor tissue from baseline to 3 weeks
measure: Change 4D Ultrasound to Traditional Cone-beam Computed Tomography (CBCT) Monitoring
timeFrame: change in imaging studies of 4D ultrasound from baseline to 3 weeks
Secondary outcomes:
measure: Change in Dosimetry Measurements
timeFrame: dosimetric changes in abdominal soft-tissue movement from baseline to the end of radiation treatment at 3 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
Study officials:
affiliation: The SKCCC at Johns Hopkins
name: Amol Narang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: