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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

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ClinicalTrials.gov Identifier: NCT01986738
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

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.

Condition or disease Intervention/treatment
Pancreatic Cancer Radiation: Standard Radiation Therapy Device: Active Breathing Control Device (ABC) Device: Computed Tomography Scan (CT)

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : January 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Radiation Treatment
Patients undergoing standard of care radiation treatment with Active Breathing Control (ABC)
Radiation: Standard Radiation Therapy
Radiotherapy will be planned and delivered according to institutional standard of care.

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



Primary Outcome Measures :
  1. Distance traveled by the pancreatic tumor during radiation treatment using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device [ Time Frame: Weeks -3 to -1, Week 1, Week 3, Week 5 ]
    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.

  2. Distance traveled by the pancreatic tumor between radiation treatments using Computed Tomography (CT) Scans and an Active Breathing Control (ABC) Device [ Time Frame: Week -3 to -1, Week 1, Week 3, Week 5 ]
    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.


Secondary Outcome Measures :
  1. Probability of surrounding normal tissue being a particular distance from the tumor marker at any time point. [ Time Frame: Week -1 to -3, Week 1, Week 3, Week 5 ]
  2. 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) [ Time Frame: Analysis will take place after treatment at approximately week 6 ]
    To assess the impact of the determined treatment margins on radiation dose distribution, we will retrospectively recalculate the patient's treatment plan based on the measured motion of the tumor and normal tissue. This new treatment plan will be compared with the original treatment plan. If the new treatment plan suggests normal tissue was exposed to a reduced amount of radiation, multiple treatment plans will be generated to assess the extent to which this reduction will allow for increased tumor dose in the future.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pancreatic cancer patients undergoing radiation treatment with active breathing control will be asked if they would like to participate.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986738


Locations
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United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Kyle Cuneo, M.D. University of Michigan Rogel Cancer Center

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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT01986738     History of Changes
Obsolete Identifiers: NCT01832142
Other Study ID Numbers: UMCC 2011.055
HUM00050677 ( Other Identifier: University of Michigan )
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases