Trial Outcomes & Findings for Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy (NCT NCT01396551)

NCT ID: NCT01396551

Last Updated: 2019-01-02

Results Overview

Whether a patient can be localized by the Calypso System using the anchored transponders will be determined during the first week (i.e., the first five fractions) of radiation therapy.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 69 participants
• Primary outcome timeframe: 1-2 weeks following implantation
• Results posted on: 2019-01-02

Participant Flow

Patients meeting inclusion/exclusion criteria and enrolled in the study were implanted with anchored transponders unless the patient's status changed prior to implantation. For example, if the patient's therapeutic plan was changed to exclude radiotherapy or the patient receives chest implants that preclude them from the study.

Participant milestones

Measure	Transponder Implantation Implantation of anchored Beacon transponder in the lung: Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung. Patients were implanted with 2-3 anchored transponders prior to radiotherapy. Transponders wereused for tumor localization during radiotherapy.
Overall Study STARTED	69
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Transponder Implantation n=69 Participants Implantation of anchored Beacon transponder in the lung: Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung. Patients were implanted with 2-3 anchored transponders prior to radiotherapy. Transponders wereused for tumor localization during radiotherapy.
Age, Continuous	65 years n=69 Participants
Sex: Female, Male Female	37 Participants n=69 Participants
Sex: Female, Male Male	32 Participants n=69 Participants
Region of Enrollment United States	41 participants n=69 Participants
Region of Enrollment South Africa	10 participants n=69 Participants
Region of Enrollment Switzerland	10 participants n=69 Participants
Region of Enrollment Germany	8 participants n=69 Participants
Tumor characteristics Primary Lung	55 Participants n=69 Participants
Tumor characteristics Recurrent/second lung primary	3 Participants n=69 Participants
Tumor characteristics Metastatic to the lung	11 Participants n=69 Participants
Co-morbidities COPD	46 Participants n=69 Participants
Co-morbidities other cardiac disease	14 Participants n=69 Participants
Co-morbidities other pulmonary conditions	13 Participants n=69 Participants
Co-morbidities Coronary Artery Bypass graft surgery	5 Participants n=69 Participants
Co-morbidities Congestive heart failure	4 Participants n=69 Participants
Co-morbidities Prior pneumothorax	4 Participants n=69 Participants
Co-morbidities Angioplasty or coronary artery stenting	3 Participants n=69 Participants
Baseline symptoms Dyspnea	39 Participants n=69 Participants
Baseline symptoms Cough	38 Participants n=69 Participants
Baseline symptoms Sputum production	24 Participants n=69 Participants
Baseline symptoms Wheezing	9 Participants n=69 Participants
Baseline symptoms Hemoptysis	3 Participants n=69 Participants
Prior Thoracic Surgery	15 Participants n=69 Participants

PRIMARY outcome

Timeframe: 1-2 weeks following implantation

Population: Two patients were not included in the analysis. One patient became ineligible for Calypso localization after receiving a pacemaker, and one patient did not undergo radiation therapy because of disease progression.

Whether a patient can be localized by the Calypso System using the anchored transponders will be determined during the first week (i.e., the first five fractions) of radiation therapy.

Outcome measures

Measure	Transponder Implantation n=67 Participants Implantation of anchored Beacon transponder in the lung: Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung. Patients were implanted with 2-3 anchored transponders prior to radiotherapy. Transponders wereused for tumor localization during radiotherapy.
To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders.	66 Participants

SECONDARY outcome

Timeframe: 1-2 weeks following implantation

The implantation procedure of the anchored transponder in the lung will be assessed with respect to a number of criteria: ability to implant transponders where intended, implanting physician's satisfaction with the process, and geometric configuration of the implanted transponders.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1-14 months, depending on the duration of radiotherapy and time between follow-up visits.

The positional stability of the anchored transponder configuration will be assessed using changes in intertransponder distance. Inter-transponder distance will be calculated from CT scans acquired at treatment planning (baseline), 2-4 subsequent follow-up CT scans acquired during radiation therapy, and 4 follow-up CT scans taking place between 10-13 months post-radiotherapy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time of implantation through the completion of the follow-up period of the study (0-14 months)

Adverse events associated with the anchored transponder and implantation procedure from the time of implantation through the completion of the follow-up period will be recorded and assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks

Target localization and tracking data will be collected with the Calypso System during radiation treatment sessions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks

To record usability data, including user intervention in response to the localization and tracking data (e.g., pausing the bean, patient re-alignment, etc.) during the radiation treatment sessions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1-2 weeks following implantation

To calculate the potential reduction in volume and dose of normal lung irradiated when routine institutional planning target volume margins are reduced to a margin of 0.5 cm circumferentially made possible by realtime localization and tracking of the tumor. This calculation will be done for a subset of the patients.

Outcome measures

Outcome data not reported

Adverse Events

Transponder Implantation

Serious events: 7 serious events

Other events: 36 other events

Deaths: 17 deaths

Serious adverse events

Measure	Transponder Implantation n=69 participants at risk Implantation of anchored Beacon transponder in the lung: Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung. Patients were implanted with 2-3 anchored transponders prior to radiotherapy. Transponders wereused for tumor localization during radiotherapy.
Infections and infestations Contiguous Pneumonia	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Infections and infestations lung infection with pulmonary abcess and bronchopleural fistula	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Respiratory, thoracic and mediastinal disorders consolidation on major fissure	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Infections and infestations acute bronchopneumonia	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Respiratory, thoracic and mediastinal disorders pneumothorax	2.9% 2/69 • Number of events 2 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Cardiac disorders anethesia induced short cardiac arrest	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Vascular disorders hypotension	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.

Other adverse events

Measure	Transponder Implantation n=69 participants at risk Implantation of anchored Beacon transponder in the lung: Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung. Patients were implanted with 2-3 anchored transponders prior to radiotherapy. Transponders wereused for tumor localization during radiotherapy.
Respiratory, thoracic and mediastinal disorders atelectasis	2.9% 2/69 • Number of events 2 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Respiratory, thoracic and mediastinal disorders imaging evidence of post obstructive pneumonia	2.9% 2/69 • Number of events 2 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Respiratory, thoracic and mediastinal disorders hemoptysis	14.5% 10/69 • Number of events 10 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Product Issues anchored transponder migration outside the lung	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Respiratory, thoracic and mediastinal disorders cough	18.8% 13/69 • Number of events 13 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Respiratory, thoracic and mediastinal disorders chest pain	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
General disorders sore throat	13.0% 9/69 • Number of events 9 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
General disorders sputum production	4.3% 3/69 • Number of events 3 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
General disorders wheezing	2.9% 2/69 • Number of events 2 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Respiratory, thoracic and mediastinal disorders post extubation bronchospasm	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
General disorders vomiting	2.9% 2/69 • Number of events 2 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Respiratory, thoracic and mediastinal disorders excoriations in oropharynx	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Respiratory, thoracic and mediastinal disorders hypoxia	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
General disorders fatigue	5.8% 4/69 • Number of events 4 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
General disorders weakness	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
General disorders fever	4.3% 3/69 • Number of events 3 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Renal and urinary disorders urinary retention	2.9% 2/69 • Number of events 2 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Respiratory, thoracic and mediastinal disorders dyspnea on exertion	2.9% 2/69 • Number of events 2 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Respiratory, thoracic and mediastinal disorders pulmonary edema	2.9% 2/69 • Number of events 2 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
General disorders nausea	2.9% 2/69 • Number of events 2 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
Respiratory, thoracic and mediastinal disorders throat/chest tightness	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
General disorders headache	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
General disorders dry mouth	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
General disorders chills	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.
General disorders neck pain	1.4% 1/69 • Number of events 1 • Adverse events were recorded from the time of patient implantation until approximately 12 months following the completion of radiotherapy.

Additional Information

Julie Allen

Varian Medical Systems

Phone: 206-330-2605

Email: julie.allen@varian.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60