KV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer

Study Overview
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Brief Summary
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This clinical trial studies if kilo-voltage cone beam computed tomography (KV-CBCT) and ultrasound imaging works in guiding radiation therapy in patients with prostate, liver, or pancreatic cancer. Computer systems, such as KV-CBCT and ultrasound imaging, allow doctors to create a 3-dimensional picture of the tumor may help in planning radiation therapy and may result in more tumor cells being killed.

Detailed Description
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PRIMARY OBJECTIVES: I. To investigate the feasibility of combining on-board cone beam computed tomography (CBCT) with ultrasound imaging to overcome the shortcomings of CBCT or ultrasound imaging alone for imaging guided radiotherapy delivery. OUTLINE: Patients undergo ultrasound imaging prior to and during radiation therapy. Patients also undergo kilo-voltage cone beam computed tomography prior to radiation therapy. Update (2021/02/04): Removed secondary outcome Incidence of Adverse Events Related to the Ultrasound Probe. Per PI: Study initially intended to involve a non-FDA approved probe for use with liver patients but removed this section.

Official Title
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Integrated 3D X-ray and Ultrasound Guided Radiation Therapy of Soft Tissue Targets

Conditions
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Adult Liver Carcinoma, Malignant Pancreatic Neoplasm, Prostate Carcinoma

Intervention / Treatment
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* Device: Cone-Beam Computed Tomography
* Radiation: 3-Dimensional Ultrasound-Guided Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have either 1) cancer involving the liver by biopsy or radiographic criteria, or 2) prostate cancer by biopsy, with the intent of undergoing definitive dose radiation therapy to targets within the liver, or prostate. Patients with prostatectomy receiving post-operative radiotherapy are also eligible. Karnofsky performance status (PS) ≥ 70 Subjects must have the ability to understand and the willingness to sign a written informational form Exclusion Criteria: Patients with uncontrolled inter-current illness or psychiatric illness/social situations that would limit compliance with study requirements

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (KV-CBCT, ultrasound-guided radiation therapy)<br>Patients undergo 3-Dimensional Ultrasound-Guided Radiation Therapy prior to and during radiation therapy. Patients also undergo kilo-voltage Cone-Beam Computed Tomography prior to radiation therapy. | Device: Cone-Beam Computed Tomography<br>* Undergo kilo-voltage cone beam computed tomography<br>Radiation: 3-Dimensional Ultrasound-Guided Radiation Therapy<br>* Undergo ultrasound-guided radiation therapy<br>* Other names: 3D Ultrasound-Guided Radiation Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Ultrasound Images Which Are Clinically Adequate for Treatment Set-up | Percentage of ultrasound images which are clinically adequate for treatment set-up in the judgment of the treating physician | Up to 1 year | 
| Number of Participants Able to Have the Ultrasound Probe Attached During the Entire Treatment Course | Proportion of participants able to have the ultrasound probe attached during the entire treatment course | Up to 1 year | 
| Percent of Patients Whose Plan Quality Was Not Not Affected in the Presence of the Ultrasound Probe | Quality of plans for patients not affected in the presence of the ultrasound probe, defined as no more than a 2% decrease in tumor coverage, and also no more than a 2% increase in the dose to the most critical normal tissue for that tumor location | Up to 1 year |