Back to resultsKV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer
Primary Purpose
Adult Liver Carcinoma, Malignant Pancreatic Neoplasm, Prostate Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cone-Beam Computed Tomography
3-Dimensional Ultrasound-Guided Radiation Therapy
Sponsored by
About this trial
This is an interventional diagnostic trial for Adult Liver Carcinoma
Eligibility Criteria
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
Sites / Locations
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (KV-CBCT, ultrasound-guided radiation therapy)
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02337465
First Posted
January 9, 2015
Last Updated
February 4, 2021
Sponsor
Case Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02337465
Brief Title
KV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer
Official Title
Integrated 3D X-ray and Ultrasound Guided Radiation Therapy of Soft Tissue Targets
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 22, 2015 (Actual)
Primary Completion Date
December 14, 2019 (Actual)
Study Completion Date
December 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Liver Carcinoma, Malignant Pancreatic Neoplasm, Prostate Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (KV-CBCT, ultrasound-guided radiation therapy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cone-Beam Computed Tomography
Intervention Description
Undergo kilo-voltage cone beam computed tomography
Intervention Type
Radiation
Intervention Name(s)
3-Dimensional Ultrasound-Guided Radiation Therapy
Other Intervention Name(s)
3D Ultrasound-Guided Radiation Therapy
Intervention Description
Undergo ultrasound-guided radiation therapy
Primary Outcome Measure Information:
Title
Percentage of Ultrasound Images Which Are Clinically Adequate for Treatment Set-up
Description
Percentage of ultrasound images which are clinically adequate for treatment set-up in the judgment of the treating physician
Time Frame
Up to 1 year
Title
Number of Participants Able to Have the Ultrasound Probe Attached During the Entire Treatment Course
Description
Proportion of participants able to have the ultrasound probe attached during the entire treatment course
Time Frame
Up to 1 year
Title
Percent of Patients Whose Plan Quality Was Not Not Affected in the Presence of the Ultrasound Probe
Description
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
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Xia, PhD
Organizational Affiliation
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Stephans, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
12. IPD Sharing Statement
Learn more about this trial
KV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer
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