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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cone-Beam Computed Tomography | Device | Undergo kilo-voltage cone beam computed tomography |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy) | 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. Cone-Beam Computed Tomography: Undergo kilo-voltage cone beam computed tomography 3-Dimensional Ultrasound-Guided Radiation Therapy: Undergo ultrasound-guided radiation therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2019 |
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| 3-Dimensional Ultrasound-Guided Radiation Therapy | Radiation | Undergo ultrasound-guided radiation therapy |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy) | 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. Cone-Beam Computed Tomography: Undergo kilo-voltage cone beam computed tomography 3-Dimensional Ultrasound-Guided Radiation Therapy: Undergo ultrasound-guided radiation therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Participants enrolled on study | Posted | Number | Percent of images | Up to 1 year |
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| Primary | 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 | Participants enrolled on study | Posted | Count of Participants | Participants | Up to 1 year |
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| |||||||||||||||||||||||||||
| Primary | 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 | Participants enrolled on study | Posted | Number | percentage of participants | Up to 1 year |
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No plan to collect adverse event data (per-protocol)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy) | 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. Cone-Beam Computed Tomography: Undergo kilo-voltage cone beam computed tomography 3-Dimensional Ultrasound-Guided Radiation Therapy: Undergo ultrasound-guided radiation therapy | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ping Xia | Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center | 1-866-223-8100 | TaussigResearch@ccf.org |
| Jan 19, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 10, 2019 | Jan 19, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D010190 | Pancreatic Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D054893 | Cone-Beam Computed Tomography |
| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| D014056 | Tomography, X-Ray |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
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| Title | Measurements |
|---|---|
|
| 70-79 years |
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| 80-89 years |
|
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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