Feasibility of Using Ultrasound to Track Respiration Motion

Sponsor
Allen Li (Other)
Overall Status
Completed
CT.gov ID
NCT02173353
Collaborator
(none)
15
1
81
0.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ultrasound

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
15 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Feasibility of Using Ultrasound to Track Respiration Motion
Actual Study Start Date :
Feb 1, 2014
Actual Primary Completion Date :
Nov 1, 2020
Actual Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Pancreas cancer

Develope a stand, cradle or robotic arm to hold the ultrasound probe, to obtain an ultrasound just before a standard radiation therapy treatment is given.

Device: Ultrasound
Ultrasound to be done just before standard radiation therapy treatment
Other Names:
  • Clarity
  • Outcome Measures

    Primary Outcome Measures

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

    1. Quality of ultrasound imaging for Pancreas [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 Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Froedtert Hospital Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Allen Li

    Investigators

    • Principal Investigator: Allen Li, PhD, Froedtert Hosptial

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Allen Li, Chief of Physics, Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT02173353
    Other Study ID Numbers:
    • IIT-LI-ELEKTA-RESPIRATION
    First Posted:
    Jun 25, 2014
    Last Update Posted:
    Dec 17, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Allen Li, Chief of Physics, Medical College of Wisconsin
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 17, 2021