KV-CBCT And Ultrasound Imaging In Guiding Radiation Therapy In Patients With Prostate, Liver, Or Pancreatic Cancer

Study Overview

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

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.

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.

Adult Liver Carcinoma
Malignant Pancreatic Neoplasm
Prostate Carcinoma

DEVICE: Cone-Beam Computed Tomography
RADIATION: 3-Dimensional Ultrasound-Guided Radiation Therapy

CASE6Y14

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-01-09	Results First Submitted 2021-02-04	Last Update Submitted that met QC Criteria 2021-02-04
First Submitted that Met QC Criteria 2015-01-09	Results First Submitted that Met QC Criteria 2021-02-04	Last Update Posted (ACTUAL) 2021-02-23
First Posted (ACTUAL) 2015-01-13	Results First Posted 2021-02-23	Last Verified 2021-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Diagnostic (KV-CBCT, ultrasound-guided radiation therapy) 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 Undergo kilo-voltage cone beam computed tomography RADIATION: 3-Dimensional Ultrasound-Guided Radiation Therapy Undergo ultrasound-guided radiation therapy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Diagnostic (KV-CBCT, ultrasound-guided radiation therapy)

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

Undergo kilo-voltage cone beam computed tomography

RADIATION: 3-Dimensional Ultrasound-Guided Radiation Therapy

Undergo ultrasound-guided radiation therapy

Primary Outcome Measures	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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

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

Patients with uncontrolled inter-current illness or psychiatric illness/social situations that would limit compliance with study requirements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Ping Xia, PhD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record