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
|Condition or disease||Intervention/treatment|
|Pancreatic Cancer||Radiation: Standard Radiation Therapy Device: Active Breathing Control Device (ABC) Device: Computed Tomography Scan (CT)|
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|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|
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)
- 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.
- 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.
- 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 ]
- 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.
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
|United States, Michigan|
|University of Michigan Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Kyle Cuneo, M.D.||University of Michigan Rogel Cancer Center|