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

Completed

• Conditions: Pancreatic Cancer
• Interventions: Radiation: Standard Radiation Therapy; Device: Active Breathing Control Device (ABC); Device: Computed Tomography Scan (CT)

• Registration Number: NCT01986738
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-11-11
• Study First Posted: 2013-11-18
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radiation Treatment	Computed Tomography Scan (CT)	Patients undergoing standard of care radiation treatment with Active Breathing Control (ABC)
Radiation Treatment	Standard Radiation Therapy	Patients undergoing standard of care radiation treatment with Active Breathing Control (ABC)
Radiation Treatment	Active Breathing Control Device (ABC)	Patients undergoing standard of care radiation treatment with Active Breathing Control (ABC)

Primary Outcome Measures

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

Name	Time	Method
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	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.

Trial Locations

Locations (1)

University of Michigan Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States