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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Carcinoma; Adult Liver Carcinoma; Malignant Pancreatic Neoplasm
• Intervention / Treatment: Device: Cone-Beam Computed Tomography; Radiation: 3-Dimensional Ultrasound-Guided Radiation Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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; Other Names: 3D Ultrasound-Guided Radiation Therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Ping Xia, PhD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center; Principal Investigator: Kevin Stephans, MD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2015
• Primary Completion (Actual): December 14, 2019
• Study Completion (Actual): December 14, 2019

Study Registration Dates

• First Submitted: January 9, 2015
• First Submitted That Met QC Criteria: January 9, 2015
• First Posted (Estimate): January 13, 2015

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Liver Diseases; Prostatic Diseases; Liver Neoplasms; Pancreatic Diseases; Prostatic Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Pancreatic Neoplasms
• Other Study ID Numbers: CASE6Y14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No