Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02111681
• Other study ID #: 13-174
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2014
• Est. completion date: April 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)
• Respiratory Aspiration

Intervention

Device:
• Calypso Beacon Implantation
Bronchoscopic Calypso Beacon Implantation

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering West Harrison	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of Calypso transponders	Feasibility is defined as completion of all treatments using the DIBH treatment plan and Calypso transponders.	2 years
Secondary	reproducibility	We will compare the visual vs no visual biofeedback treatments (done for each patient) by the number of treatment interruptions.	2 years
Secondary	measure the residual intrafraction tumor motion	will be measured in all 3 dimensions and the euclidean distance will be calculated, which will then be correlated with the normal tissue dosimetry by regression analysis.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center