Trial Outcomes & Findings for Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer (NCT NCT02111681)
NCT ID: NCT02111681
Last Updated: 2025-09-26
Results Overview
Feasibility is defined as completion of all treatments using the DIBH treatment plan and Calypso transponders.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
2 years
Results posted on
2025-09-26
Participant Flow
Participant milestones
| Measure |
Calypso-based Deep Inspiration Breath Hold (DIBH)
This trial will investigate the feasibility of implanted anchored Beacon ® electromagnetic lung transponders (Calypso ®) to guide and monitor deep-inspiration breathhold (DIBH) treatments in patients with inoperable thoracic malignancies.
Bronchoscopic Calypso Beacon Implantation, Simulation - Free-breathing scan - 4D CT scan,- DIBH CT scan Radiation - Treatment setup, - Calypso signal recording, - RT treatment with DIBH with or without visual biofeedback Follow-up - 3 and 6 months after RT with diagnostic CT chest
Calypso Beacon Implantation: Bronchoscopic Calypso Beacon Implantation
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Calypso-based Deep Inspiration Breath Hold (DIBH)
This trial will investigate the feasibility of implanted anchored Beacon ® electromagnetic lung transponders (Calypso ®) to guide and monitor deep-inspiration breathhold (DIBH) treatments in patients with inoperable thoracic malignancies.
Bronchoscopic Calypso Beacon Implantation, Simulation - Free-breathing scan - 4D CT scan,- DIBH CT scan Radiation - Treatment setup, - Calypso signal recording, - RT treatment with DIBH with or without visual biofeedback Follow-up - 3 and 6 months after RT with diagnostic CT chest
Calypso Beacon Implantation: Bronchoscopic Calypso Beacon Implantation
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Progression of disease
|
4
|
Baseline Characteristics
Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer
Baseline characteristics by cohort
| Measure |
Calypso-based Deep Inspiration Breath Hold (DIBH)
n=48 Participants
This trial will investigate the feasibility of implanted anchored Beacon ® electromagnetic lung transponders (Calypso ®) to guide and monitor deep-inspiration breathhold (DIBH) treatments in patients with inoperable thoracic malignancies.
Bronchoscopic Calypso Beacon Implantation, Simulation - Free-breathing scan - 4D CT scan,- DIBH CT scan Radiation - Treatment setup, - Calypso signal recording, - RT treatment with DIBH with or without visual biofeedback Follow-up - 3 and 6 months after RT with diagnostic CT chest
Calypso Beacon Implantation: Bronchoscopic Calypso Beacon Implantation
|
|---|---|
|
Age, Continuous
|
69 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
48 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsFeasibility is defined as completion of all treatments using the DIBH treatment plan and Calypso transponders.
Outcome measures
| Measure |
Calypso-based Deep Inspiration Breath Hold (DIBH)
n=48 Participants
This trial will investigate the feasibility of implanted anchored Beacon ® electromagnetic lung transponders (Calypso ®) to guide and monitor deep-inspiration breathhold (DIBH) treatments in patients with inoperable thoracic malignancies.
Bronchoscopic Calypso Beacon Implantation, Simulation - Free-breathing scan - 4D CT scan,- DIBH CT scan Radiation - Treatment setup, - Calypso signal recording, - RT treatment with DIBH with or without visual biofeedback Follow-up - 3 and 6 months after RT with diagnostic CT chest
Calypso Beacon Implantation: Bronchoscopic Calypso Beacon Implantation
|
|---|---|
|
Feasibility of Calypso Transponders
Participants who completed all treatments using DIBH treatment plan and Calypso transponders
|
46 Participants
|
|
Feasibility of Calypso Transponders
Participants who did not complete all treatments using DIBH treatment plan and Calypso transponders
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data not collected due to the study team being unable to secure appropriate visual feedback devices to assess this objective.
We will compare the visual vs no visual biofeedback treatments (done for each patient) by the number of treatment interruptions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearswill be measured in all 3 dimensions and the euclidean distance will be calculated in milimeters/mm, which will then be correlated with the normal tissue dosimetry by regression analysis.
Outcome measures
| Measure |
Calypso-based Deep Inspiration Breath Hold (DIBH)
n=48 Participants
This trial will investigate the feasibility of implanted anchored Beacon ® electromagnetic lung transponders (Calypso ®) to guide and monitor deep-inspiration breathhold (DIBH) treatments in patients with inoperable thoracic malignancies.
Bronchoscopic Calypso Beacon Implantation, Simulation - Free-breathing scan - 4D CT scan,- DIBH CT scan Radiation - Treatment setup, - Calypso signal recording, - RT treatment with DIBH with or without visual biofeedback Follow-up - 3 and 6 months after RT with diagnostic CT chest
Calypso Beacon Implantation: Bronchoscopic Calypso Beacon Implantation
|
|---|---|
|
Measure the Residual Intrafraction Tumor Motion
|
3 mm
Interval 2.0 to 5.0
|
Adverse Events
Calypso-based Deep Inspiration Breath Hold (DIBH)
Serious events: 8 serious events
Other events: 10 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Calypso-based Deep Inspiration Breath Hold (DIBH)
n=48 participants at risk
This trial will investigate the feasibility of implanted anchored Beacon ® electromagnetic lung transponders (Calypso ®) to guide and monitor deep-inspiration breathhold (DIBH) treatments in patients with inoperable thoracic malignancies.
Bronchoscopic Calypso Beacon Implantation, Simulation - Free-breathing scan - 4D CT scan,- DIBH CT scan Radiation - Treatment setup, - Calypso signal recording, - RT treatment with DIBH with or without visual biofeedback Follow-up - 3 and 6 months after RT with diagnostic CT chest
Calypso Beacon Implantation: Bronchoscopic Calypso Beacon Implantation
|
|---|---|
|
Gastrointestinal disorders
Esophagitis
|
2.1%
1/48 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.1%
1/48 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
2/48 • 2 years
|
|
Injury, poisoning and procedural complications
IV contrast allergy
|
2.1%
1/48 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.1%
1/48 • 2 years
|
|
Cardiac disorders
Atrial Flutter
|
2.1%
1/48 • 2 years
|
|
Infections and infestations
Bacteremia
|
2.1%
1/48 • 2 years
|
|
General disorders
Fever
|
2.1%
1/48 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.2%
3/48 • 2 years
|
Other adverse events
| Measure |
Calypso-based Deep Inspiration Breath Hold (DIBH)
n=48 participants at risk
This trial will investigate the feasibility of implanted anchored Beacon ® electromagnetic lung transponders (Calypso ®) to guide and monitor deep-inspiration breathhold (DIBH) treatments in patients with inoperable thoracic malignancies.
Bronchoscopic Calypso Beacon Implantation, Simulation - Free-breathing scan - 4D CT scan,- DIBH CT scan Radiation - Treatment setup, - Calypso signal recording, - RT treatment with DIBH with or without visual biofeedback Follow-up - 3 and 6 months after RT with diagnostic CT chest
Calypso Beacon Implantation: Bronchoscopic Calypso Beacon Implantation
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
6/48 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.1%
1/48 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.1%
1/48 • 2 years
|
|
Infections and infestations
Pneumonia
|
6.2%
3/48 • 2 years
|
|
Cardiac disorders
Supraventricular tachycardia/SVT
|
2.1%
1/48 • 2 years
|
Additional Information
Dr. Daphna Gelblum, MD
Memorial Sloan Kettering Cancer Center
Phone: 914-367-7273
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place