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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Prostate Carcinoma; Malignant Pancreatic Neoplasm; Adult Liver Carcinoma

Treatments: Radiation: 3-Dimensional Ultrasound-Guided Radiation Therapy; Device: Cone-Beam Computed Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT02337465

CASE6Y14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Diagnostic (KV-CBCT, ultrasound-guided radiation therapy)

Experimental group

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.

Treatment:

Device: Cone-Beam Computed Tomography

Radiation: 3-Dimensional Ultrasound-Guided Radiation Therapy