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

NCT02337465 | Completed Results FDA Device

• 1 other identifier: CASE6Y14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Liver Carcinoma; Malignant Pancreatic Neoplasm; Prostate Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

Cone-Beam Computed Tomography DEVICE

Undergo kilo-voltage cone beam computed tomography

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

3-Dimensional Ultrasound-Guided Radiation Therapy RADIATION

Undergo ultrasound-guided radiation therapy

Also known as: 3D Ultrasound-Guided Radiation Therapy

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with uncontrolled inter-current illness or psychiatric illness/social situations that would limit compliance with study requirements

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Pancreatic Neoplasms; Prostatic Neoplasms

Interventions

Cone-Beam Computed Tomography

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Tomography, X-Ray; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography

Results Point of Contact

• Title: Dr. Ping Xia
• Organization: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

TaussigResearch@ccf.org

1-866-223-8100

Study Officials

• Ping Xia, PhD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Kevin Stephans, MD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 13, 2015
• Study Start: September 22, 2015
• Primary Completion: December 14, 2019
• Study Completion: December 14, 2019
• Last Updated: February 23, 2021
• Results First Posted: February 23, 2021

Record last verified: 2021-02

Locations

US (1)