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

Primary Purpose

Non-small Cell Lung Cancer (NSCLC)

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Calypso Beacon Implantation
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC) focused on measuring Calypso-based Deep Inspiration Breath Hold (DIBH), radiation treatments, 13-174

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan Kettering Commack
  • Memorial Sloan Kettering West Harrison
  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Calypso-based Deep Inspiration Breath Hold (DIBH)

Arm Description

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

Outcomes

Primary Outcome Measures

feasibility of Calypso transponders
Feasibility is defined as completion of all treatments using the DIBH treatment plan and Calypso transponders.

Secondary Outcome Measures

reproducibility
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
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.

Full Information

First Posted
April 9, 2014
Last Updated
May 1, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Varian Medical Systems
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1. Study Identification

Unique Protocol Identification Number
NCT02111681
Brief Title
Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer
Official Title
Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2014 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Varian Medical Systems

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer (NSCLC)
Keywords
Calypso-based Deep Inspiration Breath Hold (DIBH), radiation treatments, 13-174

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calypso-based Deep Inspiration Breath Hold (DIBH)
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Calypso Beacon Implantation
Intervention Description
Bronchoscopic Calypso Beacon Implantation
Primary Outcome Measure Information:
Title
feasibility of Calypso transponders
Description
Feasibility is defined as completion of all treatments using the DIBH treatment plan and Calypso transponders.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
reproducibility
Description
We will compare the visual vs no visual biofeedback treatments (done for each patient) by the number of treatment interruptions.
Time Frame
2 years
Title
measure the residual intrafraction tumor motion
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Rimner, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering West Harrison
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

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

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