Clinical trial · Interventional
Improving Pancreas Radiotherapy Plans Using Respiration-driven Anatomic Deformation: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Abdominal MRI
- description
- 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.
- interventionNames
- Other: Magnetic Resonance Imaging (MRI)
Primary outcomes (1)
- 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 (1)
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available