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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986738
• Other study ID #: UMCC 2011.055
• Secondary ID: HUM00050677
• Status: Completed
• Phase: N/A
• First received: October 29, 2013
• Last updated: March 2, 2017
• Start date: January 2012
• Est. completion date: September 2013

Study information

• Verified date: March 2017
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT01832142

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Radiation:
• Standard Radiation Therapy
Radiotherapy will be planned and delivered according to institutional standard of care.

Device:
• Active Breathing Control Device (ABC)

• Computed Tomography Scan (CT)

Locations

Country	Name	City	State
United States	University of Michigan Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Weeks -3 to -1, Week 1, Week 3, Week 5
Primary	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.	Week -3 to -1, Week 1, Week 3, Week 5
Secondary	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
Secondary	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.	Analysis will take place after treatment at approximately week 6