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

Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02337465
• Other study ID #: CASE6Y14
• Status: Completed
• Phase: N/A
• Start date: September 22, 2015
• Est. completion date: December 14, 2019

Study information

• Verified date: February 2021
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 14, 2019
• Est. primary completion date: December 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Liver Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular
• Malignant Pancreatic Neoplasm
• Pancreatic Neoplasms
• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Device:
• Cone-Beam Computed Tomography
Undergo kilo-voltage cone beam computed tomography

Radiation:
• 3-Dimensional Ultrasound-Guided Radiation Therapy
Undergo ultrasound-guided radiation therapy

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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