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

NCT02024997 | Completed Early Phase 1

• 1 other identifier: IIT2012-07-YANG-MRIRESP
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic malignancy; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (1)

Abdominal MRI

EXPERIMENTAL

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)

Interventions

Magnetic Resonance Imaging (MRI) OTHER

Abdominal MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Wensha Yang, Ph.D.

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 31, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2014
• Last Updated: October 30, 2014

Record last verified: 2014-10

Locations

US (1)