A Pilot Trial to Determine the Extent of Inter- and Intra-Treatment Organ Motion Using Active Breathing Control Device (ABC) in Patients With Pancreatic Cancer

NCT ID: NCT01986738

Last Updated: 2017-03-03

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

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Radiation Treatment

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

Standard Radiation Therapy

Intervention Type RADIATION

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

Active Breathing Control Device (ABC)

Intervention Type DEVICE

Computed Tomography Scan (CT)

Intervention Type DEVICE

Interventions

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Standard Radiation Therapy

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

Intervention Type RADIATION

Active Breathing Control Device (ABC)

Intervention Type DEVICE

Computed Tomography Scan (CT)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Previous abdominal radiotherapy.
* Patients with a history of major abdominal surgery.
* Patients who are pregnant.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyle Cuneo, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

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University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00050677

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2011.055

Identifier Type: -

Identifier Source: org_study_id

NCT01832142

Identifier Type: -

Identifier Source: nct_alias

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