Feasibility of Using Ultrasound to Track Respiration Motion

NCT ID: NCT02173353

Last Updated: 2022-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2020-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Ultrasound

Intervention Type DEVICE

Ultrasound to be done just before standard radiation therapy treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound

Ultrasound to be done just before standard radiation therapy treatment

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Clarity

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

An Tai

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

An Tai, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1016/j.ijrobp.2006.12.024. Epub 2007 Feb 27.

Reference Type BACKGROUND
PMID: 17331669 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRO00020659

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.