Adult Liver Carcinoma, Malignant Pancreatic Neoplasm, Prostate Carcinoma
Conditions
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.
Interventions
DEVICECone-Beam Computed Tomography
Undergo kilo-voltage cone beam computed tomography
RADIATION3-Dimensional Ultrasound-Guided Radiation Therapy
Undergo ultrasound-guided radiation therapy
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Ultrasound Images Which Are Clinically Adequate for Treatment Set-up | 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 | 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 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy) |
|---|---|
| Age, Customized 40-49 years | 1 Participants |
| Age, Customized 50-59 years | 2 Participants |
| Age, Customized 60-69 years | 12 Participants |
| Age, Customized 70-79 years | 14 Participants |
| Age, Customized 80-89 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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
Time frame: Up to 1 year
Population: Participants enrolled on study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy) | Number of Participants Able to Have the Ultrasound Probe Attached During the Entire Treatment Course | 29 Participants |
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
Time frame: Up to 1 year
Population: Participants enrolled on study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy) | Percentage of Ultrasound Images Which Are Clinically Adequate for Treatment Set-up | 100 Percent of images |
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
Time frame: Up to 1 year
Population: Participants enrolled on study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy) | Percent of Patients Whose Plan Quality Was Not Not Affected in the Presence of the Ultrasound Probe | 100 percentage of participants |