Non-small Cell Lung Cancer (NSCLC)
Conditions
Keywords
Calypso-based Deep Inspiration Breath Hold (DIBH), radiation treatments, 13-174
Brief summary
The purpose of this study is to test the use of Calypso beacon implants as a way to determine where the lung tumor is located during radiation treatment. The Calypso beacons are small devices that are implanted in the lungs, near the tumor. They are able to send a signal to a tracking system to show where they are, and where the tumor is, as the patient holds their breath for the radiation treatment. The investigators want to find out what effects, good and/or bad, that this has on the patient and the way they treat the cancer in your lungs.
Interventions
DEVICECalypso Beacon Implantation
Bronchoscopic Calypso Beacon Implantation
Sponsors
Varian Medical Systems
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have histologic proof of malignancy suitable for thoracic radiation therapy * Patients planning to undergo radiation therapy for primary or recurrent malignancy of the lung or metastatic malignancy to the lung. * Age ≥ 18 years old * KPS ≥ 60% * Ability to hold their breath for \>20 seconds for 5 times * Patients who are able to tolerate flexible bronchoscopy * Patients with life expectancy of at least 12 months * Patients able to have bronchoscopic placement of Calypso as confirmed on a recent (within the past 8 weeks) CT scan. * Patients who are able to comply with the protocol follow-up schedule.
Exclusion criteria
* Patients unable to comply with instructions for DIBH * Patients with implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which Calypso Medical considers will interfere with the Calypso System's electromagnetic localization. * Patients with active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps since the effects of the Calypso System operation on these devices are unknown. * Patients with clinically significant active infections. * Patients with bronchiectasis in the region of the intended implantation sites. * Patients with a history of hypersensitivity to nickel. * Patients whose lung tumors are being monitored with MR imaging (MR imaging of the anchored transponders is safe but yields an image artifact around the anchored transponders). * Posterior lesions that would be \>19cm distance from Calypso detector plate. Patients may be treated in the prone position in order to meet the required minimum distance. * Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study. * Patients who are deemed unable to safely undergo or tolerate flexible bronchoscopy * Patients who are unable to tolerate anesthesia or sedation * Patients enrolled in any other clinical studies the investigator believes to be in conflict with this investigation. * Female patients who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Calypso Transponders | 2 years | Feasibility is defined as completion of all treatments using the DIBH treatment plan and Calypso transponders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility | 2 years | We will compare the visual vs no visual biofeedback treatments (done for each patient) by the number of treatment interruptions. |
| Measure the Residual Intrafraction Tumor Motion | 2 years | will 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Progression of disease | 4 |
Baseline characteristics
| Characteristic | Calypso-based Deep Inspiration Breath Hold (DIBH) |
|---|---|
| Age, Continuous | 69 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 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 | 40 Participants |
| Region of Enrollment United States | 48 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 30 / 48 |
| other Total, other adverse events | 10 / 48 |
| serious Total, serious adverse events | 8 / 48 |
Outcome results
Primary
Feasibility of Calypso Transponders
Feasibility is defined as completion of all treatments using the DIBH treatment plan and Calypso transponders.
Time frame: 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Calypso-based Deep Inspiration Breath Hold (DIBH) | Feasibility of Calypso Transponders | Participants who completed all treatments using DIBH treatment plan and Calypso transponders | 46 Participants |
| Calypso-based Deep Inspiration Breath Hold (DIBH) | Feasibility of Calypso Transponders | Participants who did not complete all treatments using DIBH treatment plan and Calypso transponders | 2 Participants |
Secondary
Measure the Residual Intrafraction Tumor Motion
will 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.
Time frame: 2 years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Calypso-based Deep Inspiration Breath Hold (DIBH) | Measure the Residual Intrafraction Tumor Motion | 3 mm |
Secondary
Reproducibility
We will compare the visual vs no visual biofeedback treatments (done for each patient) by the number of treatment interruptions.
Time frame: 2 years
Population: Data not collected due to the study team being unable to secure appropriate visual feedback devices to assess this objective.