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A Pilot Trial to Determine the Extent of Inter- and Intra-Treatment Organ Motion Using Active Breathing Control (ABC) in Patients With Pancreatic Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

A Pilot Trial to Determine the Extent of Inter- and Intra-Treatment Organ Motion Using Active Breathing Control (ABC) in Patients With Pancreatic Cancer


In this study, 10 patients undergoing treatment for pancreatic cancer using ABC will undergo
three CT scans in addition to their treatment planning simulation CT, during the first,
third and fifth week of a five week course of chemoradiation. These will assess motion of
their pancreatic tumors by tracking the implanted gold fiducial markers to assess intra and
inter-fraction reproducibility. The patients would hold their breath 3 times during which a
CT of the abdomen would be performed.. The intent of this study is to utilize these markers
to gain understanding of pancreas motion for patients treated using ABC to limit this
motion, and the reproducibility of ABC use during and between treatments. The results of
this study would allow us to further refine the radiation delivery margins for future
patients undergoing this treatment. This study would be purely observational and we do not
anticipate the use of this information to affect the current patients on study.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Characterize patient-specific intra- and inter-fraction target movement (measure in millimeters) in pancreatic cancer patients undergoing radiation treatment with active breathing control.

Outcome Time Frame:

5 weeks

Safety Issue:

No

Principal Investigator

Mary Feng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Food and Drug Administration

Study ID:

HUM00050677

NCT ID:

NCT01832142

Start Date:

January 2012

Completion Date:

January 2015

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752