Improving Pancreas Radiotherapy Plans Using Respiration-driven Anatomic Deformation: A Pilot Study

Study Overview

The overall aim of this study is to investigate a novel ȭual instance" planning method to make use of the respiratory motion to improve pancreatic radiation therapy (RT) treatment planning. Specific Aim 1: Acquire patient abdominal MRI and CT at both deep inspiration (INSP) and expiration (EXP) positions and characterize the changes in geometric relationships between the INSP and EXP instances for tumor and normal tissues including stomach, duodenum and bowel. We hypothesize that INSP and EXP MRI and CT characterization will allow identification of patients who may benefit from the dual instance planning method. Specific Aim 2: Develop, investigate and evaluate plans based on free breathing, single instance breath hold, and the novel dual instance anatomical information. We hypothesize that use of the dual instance method will lead to improved plans, demonstrated by the ability to increase dose to the target, while maintaining the clinically-accepted normal tissue dose constraints.

N/A

Pancreatic Cancer

OTHER: Magnetic Resonance Imaging (MRI)

IIT2012-07-YANG-MRIRESP

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-12-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-10-29
First Submitted that Met QC Criteria 2013-12-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-10-30
First Posted (ESTIMATED) 2013-12-31	Results First Posted N/A	Last Verified 2014-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Basic Science

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Abdominal MRI Subjects will undergo magnetic resonance imaging (MRI) with contrast. Magnetic resonance (MR)_freebreathing scan will be acquired. MR_inspiration scan will be acquired. MR_expiration scan will be acquired.	OTHER: Magnetic Resonance Imaging (MRI)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Abdominal MRI

Subjects will undergo magnetic resonance imaging (MRI) with contrast. Magnetic resonance (MR)_freebreathing scan will be acquired. MR_inspiration scan will be acquired. MR_expiration scan will be acquired.

OTHER: Magnetic Resonance Imaging (MRI)

Primary Outcome Measures	Measure Description	Time Frame
Compare magnetic resonance (MR) in different breath-hold phases to quantify respiration induced anatomic changes		Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)

Secondary Outcome Measures	Measure Description	Time Frame
Modeling the feasibility of the dose escalation using respiration induced anatomic changes		Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Any patient with a biopsy proven diagnosis of malignancy involving the pancreas to be treated with radiation therapy
Age >18 years
Ability to understand and the willingness to sign a written informed consent document
Creatinine or creatinine clearance of <1.5 times the upper limit of normal or >45 mL/min/1.73m2 for patients with creatinine levels above normal. Modification of Diet in Renal Disease (MDRD) formula was used to calculate the creatinine level

Patients who are currently receiving any investigational agents
Unable to undergo MRIs
Patients with late stage kidney disease or who have had a liver transplant
Individuals who are allergic to animal dander or have asthma that may be enflamed by proximity to animals will be excluded as the scans will take place in a facility where animal research is also performed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Wensha Yang, Ph.D., Cedars-Sinai Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record