Feasibility of Using Ultrasound to Track Respiration Motion

Pancreatic Neoplasms Clinical Trial

Official title:

Feasibility of Using Ultrasound to Track Respiration Motion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173353
• Other study ID #: PRO00020659
• Status: Completed
• Start date: February 2014
• Est. completion date: November 2020

Study information

• Verified date: October 2022
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of using ultrasound to image and track pancreas/duodenum motion during radiation therapy treatment delivery. Also develop a workflow and process to allow the final ultrasound system to be used routinely by radiation therapists.

Description:

1. Acquire 2D and 3D ultrasound images for 5 pancreatic cancer patients using the existing Clarity system with a hand-held probe. The visibility of pancreas, duodenum, and other organs will be evaluated. Based on this image acquisition experience, design and construct stands to hold the ultrasound probe. Issues to be considered in the design include (i) avoiding the stand and probe blocking radiation beams, (ii) avoiding ultrasound going through the ribs, (iii) minimizing the effect of respiration motion. Also explore building the probe into the immobilization device (e.g., Alpha cradle) or using robotic arm.

2. Acquire ultrasound images for 20 patients with pancreatic cancer treated in the Department of Radiation Oncology department using the tools developed in Aim 1. As the standard practice, the 4 dimensional CT (4DCT) and 4 dimensional (4D) morphological and physiological MRI (T1, T2, apparent diffusion coefficient, DWI) will be acquired for treatment planning, and a respiration-gated CT will be acquired immediately before the delivery of each fraction using an in-room CT or cone-beam CT for patient positioning. The ultrasound images may be acquired during initial simulation immediately before or after the planning 4DCT and the daily gated CT, and during the treatment delivery in 2D, 3D and/or 4D modes. All raw ultrasound data will be stored.

3. Process ultrasound data acquired above to evaluate the effectiveness of using ultrasound to image and to track pancreas/duodenum motion during the treatment delivery. The images will be processed to visualize pancreas and/or surrogates, such as the boundary between pancreas and duodenum, infusion catheter. To improve the visible appearance, elastography will be explored by processing the raw data collected in Aim 2. Existing software will be used, and may be modified if necessary, to segment and to register ultrasound with CT. A tool the investigators previous develop for multimodality registration will be used to register ultrasound with MRI. Anatomic markers, such as the boundary between pancreas head and duodenum, stent, infusion catheter, may be used for registration and/or motion tracking.

4. Develop/modify workflow and process to allow the final system to be used routinely by radiation therapists. If necessary, user-friendly software tools will be developed/incorporated in the final system.

5. Explore the use of Doppler mode for tissue characterization and the potential of using it to image radiation effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who will receive standard radiation therapy for pancreas cancer

Exclusion Criteria:

• Patients who will receive standard radiation therapy for sites other than pancreas cancer

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Device:
• Ultrasound
Ultrasound to be done just before standard radiation therapy treatment

Locations

Country	Name	City	State
United States	Froedtert Hospital & the Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (1)

Li XA, Qi XS, Pitterle M, Kalakota K, Mueller K, Erickson BA, Wang D, Schultz CJ, Firat SY, Wilson JF. Interfractional variations in patient setup and anatomic change assessed by daily computed tomography. Int J Radiat Oncol Biol Phys. 2007 Jun 1;68(2):581-91. Epub 2007 Feb 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess organ motion and compare in conjunction with magnetic resonance imaging or CT	Process ultrasound data acquired to evaluate the effectiveness of using ultrasound to image and to track pancreas/duodenum motion during the treatment delivery. Develop/modify workflow and process to allow the final system to be used routinely by radiation therapists. If necessary, user-friendly software tools will be developed/incorporated in the final system. Explore the use of Doppler mode for tissue characterization and the potential of using it to image radiation effects.	5 years from the date of enrollment
Primary	Evaluate the use of ultrasound to detect motion of pancrease and surrounding structures	Design and construct stands to hold the ultrasound probe. Issues to be considered in the design include (i) avoiding the stand and probe blocking radiation beams, (ii) avoiding ultrasound going through the ribs, (iii) minimizing the effect of respiration motion. Explore building the probe into the immobilization device (e.g., Alpha cradle) or using robotic arm.	5 years from the date of enrollment
Secondary	Quality of ultrasound imaging for Pancreas	Acquire ultrasound images for 20 patients with the immobilization device (e.g., Alpha cradle) or using a robotic arm.	3 years from the date of enrollment