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Completed

NCT Number: NCT02173353

Feasibility of Using Ultrasound to Track Respiration Motion

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

  • 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.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Device

Ultrasound to be done just before standard radiation therapy treatment

Other names: Clarity

Primary outcomes

  1. Evaluate the use of ultrasound to detect motion of pancrease and surrounding structures

    Time frame: 5 years from the date of enrollment

    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.

Secondary outcomes

  1. Quality of ultrasound imaging for Pancreas

    Time frame: 3 years from the date of enrollment

    Acquire ultrasound images for 20 patients with the immobilization device (e.g., Alpha cradle) or using a robotic arm.

Other outcomes

  1. Assess organ motion and compare in conjunction with magnetic resonance imaging or CT

    Time frame: 5 years from the date of enrollment

    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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jun 25, 2014
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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