Clinical trial NCT02337465: 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
Overall status: COMPLETED
Phase: NA
Conditions: Adult Liver Carcinoma
Malignant Pancreatic Neoplasm
Prostate Carcinoma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Percentage of Ultrasound Images Which Are Clinically Adequate for Treatment Set-up
timeFrame: Up to 1 year
measure: Number of Participants Able to Have the Ultrasound Probe Attached During the Entire Treatment Course
timeFrame: Up to 1 year
measure: Percent of Patients Whose Plan Quality Was Not Not Affected in the Presence of the Ultrasound Probe
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
name: Ping Xia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
name: Kevin Stephans, MD
role: PRINCIPAL_INVESTIGATOR
References: