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

NCT ID: NCT02337465

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-22
• Study Completion Date: 2019-12-14

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.

Conditions

Adult Liver Carcinoma; Malignant Pancreatic Neoplasm; Prostate Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cone-Beam Computed Tomography

Intervention Type: DEVICE

Undergo kilo-voltage cone beam computed tomography

3-Dimensional Ultrasound-Guided Radiation Therapy

Intervention Type: RADIATION

Undergo ultrasound-guided radiation therapy

Interventions

Cone-Beam Computed Tomography

Undergo kilo-voltage cone beam computed tomography

Intervention Type: DEVICE

3-Dimensional Ultrasound-Guided Radiation Therapy

Undergo ultrasound-guided radiation therapy

Intervention Type: RADIATION

Other Intervention Names

3D Ultrasound-Guided Radiation Therapy

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ping Xia, PhD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Kevin Stephans, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CASE6Y14

Identifier Type: -

Identifier Source: org_study_id