- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02024997
Improving Pancreas Radiotherapy Plans Using Respiration-driven Anatomic Deformation: A Pilot Study
The overall aim of this study is to investigate a novel "dual 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare magnetic resonance (MR) in different breath-hold phases to quantify respiration induced anatomic changes
Time Frame: Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)
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Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Modeling the feasibility of the dose escalation using respiration induced anatomic changes
Time Frame: Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)
|
Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wensha Yang, Ph.D., Cedars-Sinai Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IIT2012-07-YANG-MRIRESP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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