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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02337465
Recruitment Status : Recruiting
First Posted : January 13, 2015
Last Update Posted : August 14, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Adult Liver Carcinoma Malignant Pancreatic Neoplasm Prostate Carcinoma Device: Cone-Beam Computed Tomography Radiation: 3-Dimensional Ultrasound-Guided Radiation Therapy Not Applicable

Detailed Description:


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.


Patients undergo ultrasound imaging prior to and during radiation therapy. Patients also undergo kilo-voltage cone beam computed tomography prior to radiation therapy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Integrated 3D X-ray and Ultrasound Guided Radiation Therapy of Soft Tissue Targets
Actual Study Start Date : September 22, 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

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 Name: 3D Ultrasound-Guided Radiation Therapy

Primary Outcome Measures :
  1. 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 ]
  2. Percentage of patients able to have the ultrasound probe attached during the entire treatment course [ Time Frame: Up to 1 year ]
  3. 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 ]
  4. Incidence of adverse events related to the ultrasound probe [ Time Frame: Up to 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02337465

United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Ping Xia    216-444-1938   
Principal Investigator: Ping Xia         
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
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

Responsible Party: Case Comprehensive Cancer Center Identifier: NCT02337465     History of Changes
Other Study ID Numbers: CASE6Y14
NCI-2014-02278 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE 6Y14 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Pancreatic Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liver Neoplasms
Liver Diseases