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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02024997
Enrollment
15
Registered
2013-12-31
Start date
2013-01-31
Completion date
Unknown
Last updated
2014-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Pancreatic malignancy, Radiation Therapy

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.

Interventions

OTHERMagnetic Resonance Imaging (MRI)

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Compare magnetic resonance (MR) in different breath-hold phases to quantify respiration induced anatomic changesBaseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)

Secondary

MeasureTime frame
Modeling the feasibility of the dose escalation using respiration induced anatomic changesBaseline only (at least 3 days after CT simulation and up to 1 week after the initiation of radiation treatment)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026