Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy

NCT01396551 | Completed Results FDA Device

• 1 other identifier: CMT - 01-10
• Study Type: interventional
• Target: 69
• Locations: 4 countries
• Sites: 10

Brief Summary

Clinical study investigating the feasibility and safety of using an anchored Calypso transponder in the airways of the lung for real-time monitoring of tumor location during radiotherapy

Conditions

Lung Cancer

Keywords

Anchored Beacon Transponder; Anchored Transponder; Lung cancer; Calypso system; Realtime tracking

Outcome Measures

Primary Outcomes (1)

• To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders.

  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.

  1-2 weeks following implantation

Secondary Outcomes (6)

• To Assess the Implantation Procedure of the Anchored Transponder in the Lung

  1-2 weeks following implantation

• To Assess the Positional Stability of the Anchored Transponders Short Term Through the Completion of Radiotherapy and Long Term Through One Year of Follow-up.

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

• To Evaluate Adverse Events Associated With the Anchored Transponder and the Implantation Procedure

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

• To Collect Target Localization and Tracking Data With the Calypso System During Radiation Treatment Sessions

  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 During the Radiation Treatment Sessions

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

Study Arms (1)

Transponder implantation

EXPERIMENTAL

Implantation of anchored Beacon transponder in the lung

Device: Implantation of anchored Beacon transponder in the lung

Interventions

Implantation of anchored Beacon transponder in the lung DEVICE

Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung.

Transponder implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at time of consent (19 years if required by local or state laws)
• Patients planning to undergo radiation therapy for primary or recurrent carcinomas of the lung or cancer that is metastatic to the lung.
• Patients who are to receive 30 Gy or more of external beam radiation therapy.
• Patients who are able to tolerate flexible bronchoscopy.
• Patients with life expectancy of at least 12 months and who are expected to be able to complete the full follow-up assessment in the protocol.
• Patients for whom the physician is able to identify suitable implantation sites for the anchored transponders on a recent (within the past 8 weeks) CT scan. This will require acquisition of a CT scan if a suitable one is not already available.
• Patients who are able to comply with the protocol.

You may not qualify if:

• Patients with implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which the Sponsor considers will interfere with the Calypso System's electromagnetic localization (note that the Sponsor will review a patient's implanted metal on a case by case basis).
• Patients with active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps since the effect of the Calypso System operation on these devices is unknown.
• Patients with active infections.
• Patients with bronchiectasis in the lobe 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).
• 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 enrolled in any other clinical studies the investigator believes to be in conflict with this investigation.

Sponsors & Collaborators

• Varian, a Siemens Healthineers Company: lead

Study Sites (10)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Radiological Associates of Sacramento

Sacramento, California, 95815, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Cancer Treatment Centers of America (CTCA)

Tulsa, Oklahoma, 74133, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Heidelberg / Thoraxklinik / DKFZ

Heidelberg, Germany

Location

Stellenbosch University / Tygerberg Hospital

Cape Town, South Africa

Location

University Hospital Basel

Basel, Switzerland

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Julie Allen
• Organization: Varian Medical Systems

julie.allen@varian.com

206-330-2605

Study Officials

• Lisa Levine, PhD

  Varian Medical Systems

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 19, 2011
• Study Start: October 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 2, 2019
• Results First Posted: January 2, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); CH (1); DE (1); ZA (1)