Adult Liver CarcinomaNCT02337465
KV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer
A study testing Cone-Beam Computed Tomography and 3-Dimensional Ultrasound-Guided Radiation Therapy in people with Adult Liver Carcinoma and Malignant Pancreatic Neoplasm, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adult Liver Carcinoma, Malignant Pancreatic Neoplasm, Prostate Carcinoma
- What is being tested?
- Cone-Beam Computed Tomography and 3-Dimensional Ultrasound-Guided Radiation Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2015to 14 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with uncontrolled inter-current illness or psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Integrated 3D X-ray and Ultrasound Guided Radiation Therapy of Soft Tissue Targets
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Cone-Beam Computed Tomography, 3-Dimensional Ultrasound-Guided Radiation Therapy
- Medical subject headings
- Carcinoma, Hepatocellular, Pancreatic Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone-Beam Computed TomographyDevice
Undergo kilo-voltage cone beam computed tomography
3-Dimensional Ultrasound-Guided Radiation TherapyRadiation
Also called 3D Ultrasound-Guided Radiation Therapy
Undergo ultrasound-guided radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cone-Beam Computed Tomography; Radiation: 3-Dimensional Ultrasound-Guided Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study start22 Sep 2015
- Primary completion14 Dec 2019
- Study completion14 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult Liver CarcinomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping Xia, PhD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer CenterKevin Stephans, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337465
- Sponsor's protocol ID
- CASE6Y14
- Status last verified
- Feb 2021
- First submitted
- 9 Jan 2015
- Last updated
- 23 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated 3D X-ray and Ultrasound Guided Radiation Therapy of Soft Tissue Targets
- ClinicalTrials.gov ID
- NCT02337465
- Acronym / sponsor ID
- CASE6Y14
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 22 Sep 2015 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 14 Dec 2019 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Posted 23 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (KV-CBCT, ultrasound-guided radiation therapy) | Experimental | Device: Cone-Beam Computed Tomography, Radiation: 3-Dimensional Ultrasound-Guided Radiation TherapyPatients 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with uncontrolled inter-current illness or psychiatric illness/social situations that would limit compliance with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cone-Beam Computed TomographyUndergo kilo-voltage cone beam computed tomography | Device | Diagnostic (KV-CBCT, ultrasound-guided radiation therapy) |
| 3-Dimensional Ultrasound-Guided Radiation TherapyAlso: 3D Ultrasound-Guided Radiation TherapyUndergo ultrasound-guided radiation therapy | Radiation | Diagnostic (KV-CBCT, ultrasound-guided radiation therapy) |
Primary outcome
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping Xia, PhD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Kevin Stephans, MD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cone-Beam Computed Tomography and 3-Dimensional Ultrasound-Guided Radiation Therapy in people with Adult Liver Carcinoma and Malignant Pancreatic Neoplasm, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Ultrasound Images Which Are Clinically Adequate for Treatment Set-up (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.