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NCT Number: NCT02337465

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

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.

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Key information

Conditions

Adult Liver Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Liver Diseases Liver Neoplasms Male Urogenital Diseases Malignant Pancreatic Neoplasm Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms Prostate Carcinoma Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cone-Beam Computed Tomography

Device

Undergo kilo-voltage cone beam computed tomography

3-Dimensional Ultrasound-Guided Radiation Therapy

Radiation

Undergo ultrasound-guided radiation therapy

Other names: 3D Ultrasound-Guided Radiation Therapy

Primary outcomes

  1. Percentage of Ultrasound Images Which Are Clinically Adequate for Treatment Set-up

    Time frame: Up to 1 year

    Percentage of ultrasound images which are clinically adequate for treatment set-up in the judgment of the treating physician

  2. Number of Participants Able to Have the Ultrasound Probe Attached During the Entire Treatment Course

    Time frame: Up to 1 year

    Proportion of participants able to have the ultrasound probe attached during the entire treatment course

  3. Percent of Patients Whose Plan Quality Was Not Not Affected in the Presence of the Ultrasound Probe

    Time frame: Up to 1 year

    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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2015
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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