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

N/ACompletedNCT01986738

University of Michigan Rogel Cancer Center9 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pancreatic Cancer

Interventions

Standard Radiation TherapyRADIATION

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

Active Breathing Control Device (ABC)DEVICE

Computed Tomography Scan (CT)DEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Week -3 to -1, Week 1, Week 3, Week 5

Secondary Outcomes

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)

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.