Clinical trial NCT02024997: Improving Pancreas Radiotherapy Plans Using Respiration-driven Anatomic Deformation: A Pilot Study
Official title: Improving Pancreas Radiotherapy Plans Using Respiration-driven Anatomic Deformation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pancreatic Cancer
Keywords: Pancreatic malignancy
Radiation Therapy
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Compare magnetic resonance (MR) in different breath-hold phases to quantify respiration induced anatomic changes
timeFrame: Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)
Secondary outcomes:
measure: Modeling the feasibility of the dose escalation using respiration induced anatomic changes
timeFrame: Baseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Wensha Yang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: