NCT01986738

Brief Summary

This is a study to assess the motion of pancreatic tumors during radiation therapy using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

October 29, 2013

Last Update Submit

March 2, 2017

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

  • Distance traveled by the pancreatic tumor during radiation treatment using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device

    A marker (implanted near the radiation site, prior to treatment, as a point of reference) will be noted in space on an x, y and z plane using a CT scan. The excursion of this marker during treatment will be determined and the distance traveled, as well as the overall vector (distance and magnitude), will be calculated. Later scans will assess changes in the ability to calculate distance traveled and overall vector of travel.

    Weeks -3 to -1, Week 1, Week 3, Week 5

  • Distance traveled by the pancreatic tumor between radiation treatments using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device

    A marker (implanted near the radiation site prior to treatment as a point of reference) will be noted in space on an x, y and z plane on a pre-treatment/planning Computed Tomography (CT) scan. The relative position of the marker on later CT scans will be compared to the pre-treatment/planning scan and the difference in position will be calculated. The change in the position between all CT scans will be calculated for statistical analysis of tumor movement while undergoing treatment with an Active Breathing Control (ABC) Device.

    Week -3 to -1, Week 1, Week 3, Week 5

Secondary Outcomes (2)

  • Probability of surrounding normal tissue being a particular distance from the tumor marker at any time point.

    Week -1 to -3, Week 1, Week 3, Week 5

  • Assess the impact of the determined treatment margins on the radiation dose to normal tissues and the ability to escalate dose to the tumor using Intensity-Modulated Radiation Therapy (IMRT)

    Analysis will take place after treatment at approximately week 6

Study Arms (1)

Radiation Treatment

Patients undergoing standard of care radiation treatment with Active Breathing Control (ABC)

Radiation: Standard Radiation TherapyDevice: Active Breathing Control Device (ABC)Device: Computed Tomography Scan (CT)

Interventions

Standard Radiation TherapyRADIATION

Radiotherapy will be planned and delivered according to institutional standard of care.

Radiation Treatment
Active Breathing Control Device (ABC)DEVICE
Radiation Treatment
Computed Tomography Scan (CT)DEVICE
Radiation Treatment

Eligibility Criteria

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

pancreatic cancer patients undergoing radiation treatment with active breathing control will be asked if they would like to participate.

You may qualify if:

  • Patients ≥ 18 years of age
  • A working diagnosis (with or without histologic confirmation) of pancreatic cancer
  • A plan to treat with radiotherapy (or chemoradiotherapy)
  • Patients must have fiducial marker(s) endoscopically placed within the pancreas for clinical treatment.

You may not qualify if:

  • Previous abdominal radiotherapy.
  • Patients with a history of major abdominal surgery.
  • Patients who are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Kyle Cuneo, M.D.

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2013

First Posted

November 18, 2013

Study Start

January 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

US(1)