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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02024997
• Other study ID #: IIT2012-07-YANG-MRIRESP
• Status: Completed
• Phase: Phase 0
• First received: December 18, 2013
• Last updated: October 29, 2014
• Start date: January 2013

Study information

• Verified date: October 2014
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• Magnetic Resonance Imaging (MRI)

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No