Trial Outcomes & Findings for KV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer (NCT NCT02337465)

Last Updated: 2021-02-23

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2021-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy) n=30 Participants 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
Age, Customized 40-49 years	1 Participants n=5 Participants
Age, Customized 50-59 years	2 Participants n=5 Participants
Age, Customized 60-69 years	12 Participants n=5 Participants
Age, Customized 70-79 years	14 Participants n=5 Participants
Age, Customized 80-89 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: Participants enrolled on study

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

Outcome measures

Outcome measures
Measure	Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy) n=30 Participants Participants undergo 3-Dimensional Ultrasound-Guided Radiation Therapy prior to and during radiation therapy. Participants 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
Percentage of Ultrasound Images Which Are Clinically Adequate for Treatment Set-up	100 Percent of images

PRIMARY outcome

Timeframe: Up to 1 year

Population: Participants enrolled on study

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

Outcome measures

Outcome measures
Measure	Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy) n=30 Participants Participants undergo 3-Dimensional Ultrasound-Guided Radiation Therapy prior to and during radiation therapy. Participants 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
Number of Participants Able to Have the Ultrasound Probe Attached During the Entire Treatment Course	29 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: Participants enrolled on study

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

Outcome measures

Outcome measures
Measure	Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy) n=30 Participants Participants undergo 3-Dimensional Ultrasound-Guided Radiation Therapy prior to and during radiation therapy. Participants 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
Percent of Patients Whose Plan Quality Was Not Not Affected in the Presence of the Ultrasound Probe	100 percentage of participants

Adverse Events

Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ping Xia

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Phone: 1-866-223-8100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place