NCT02173353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

6.8 years

First QC Date

June 17, 2014

Last Update Submit

October 7, 2022

Conditions

Keywords

UltrasoundPancreatic NeoplasmsRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quality of ultrasound imaging for Pancreas

    3 years from the date of enrollment

Other Outcomes (1)

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

    5 years from the date of enrollment

Study Arms (1)

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

Interventions

Ultrasound to be done just before standard radiation therapy treatment

Also known as: Clarity
Pancreas cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who will receive standard radiation therapy for pancreas cancer.

You may qualify if:

  • Patients who will receive standard radiation therapy for pancreas cancer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

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

    PMID: 17331669BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • An Tai, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 25, 2014

Study Start

February 1, 2014

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

October 12, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations