Trial Outcomes & Findings for Novel Optical Surface Image Guidance System for Beam-Gated Online Adaptive SBRT Delivery in Mobile Lower Lung and Upper Abdominal Malignancies (NCT NCT05030454)
NCT ID: NCT05030454
Last Updated: 2023-04-18
Results Overview
Success will be defined as delivery of a given treatment fraction in one on-table attempt, without requiring use of a secondary (backup) motion management system, or alternative treatment machine. Unsuccessful delivery of a fraction will be defined as multiple attempts for gating without reproducible positioning, breath-hold, and/or surface guidance feedback, such that the fraction is abandoned.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Through completion of treatment (estimated to be 2 weeks)
Results posted on
2023-04-18
Participant Flow
Participant milestones
| Measure |
CT-guided Stereotactic Adaptive Radiotherapy
-Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Novel Optical Surface Image Guidance System for Beam-Gated Online Adaptive SBRT Delivery in Mobile Lower Lung and Upper Abdominal Malignancies
Baseline characteristics by cohort
| Measure |
CT-guided Stereotactic Adaptive Radiotherapy
n=10 Participants
-Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments.
|
|---|---|
|
Age, Continuous
|
72 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Through completion of treatment (estimated to be 2 weeks)Success will be defined as delivery of a given treatment fraction in one on-table attempt, without requiring use of a secondary (backup) motion management system, or alternative treatment machine. Unsuccessful delivery of a fraction will be defined as multiple attempts for gating without reproducible positioning, breath-hold, and/or surface guidance feedback, such that the fraction is abandoned.
Outcome measures
| Measure |
CT-guided Stereotactic Adaptive Radiotherapy
n=50 Treatment fractions
-Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments.
|
|---|---|
|
Percentage of Scheduled Treatment Fractions Delivered Successfully Using the Surface Guidance System
|
100 percentage of treatment fractions
|
Adverse Events
CT-guided Stereotactic Adaptive Radiotherapy
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CT-guided Stereotactic Adaptive Radiotherapy
n=10 participants at risk
-Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments.
|
|---|---|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment through 3 months following the last day of SBRT with the length of follow-up ranging from 3 months and 1 week for those who received their radiotherapy fraction daily or 3 months and 2 weeks for those who received their radiotherapy fraction every other day.
|
Other adverse events
| Measure |
CT-guided Stereotactic Adaptive Radiotherapy
n=10 participants at risk
-Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments.
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment through 3 months following the last day of SBRT with the length of follow-up ranging from 3 months and 1 week for those who received their radiotherapy fraction daily or 3 months and 2 weeks for those who received their radiotherapy fraction every other day.
|
|
Gastrointestinal disorders
Epigastric pain radiating to the back
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment through 3 months following the last day of SBRT with the length of follow-up ranging from 3 months and 1 week for those who received their radiotherapy fraction daily or 3 months and 2 weeks for those who received their radiotherapy fraction every other day.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment through 3 months following the last day of SBRT with the length of follow-up ranging from 3 months and 1 week for those who received their radiotherapy fraction daily or 3 months and 2 weeks for those who received their radiotherapy fraction every other day.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment through 3 months following the last day of SBRT with the length of follow-up ranging from 3 months and 1 week for those who received their radiotherapy fraction daily or 3 months and 2 weeks for those who received their radiotherapy fraction every other day.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment through 3 months following the last day of SBRT with the length of follow-up ranging from 3 months and 1 week for those who received their radiotherapy fraction daily or 3 months and 2 weeks for those who received their radiotherapy fraction every other day.
|
|
General disorders
Body aches
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment through 3 months following the last day of SBRT with the length of follow-up ranging from 3 months and 1 week for those who received their radiotherapy fraction daily or 3 months and 2 weeks for those who received their radiotherapy fraction every other day.
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment through 3 months following the last day of SBRT with the length of follow-up ranging from 3 months and 1 week for those who received their radiotherapy fraction daily or 3 months and 2 weeks for those who received their radiotherapy fraction every other day.
|
Additional Information
Pamela Samson, M.D., MPHS
Washington University School of Medicine
Phone: 314-747-1786
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place