Calypso Guided High Precision Stereotactic Ablative Radiosurgery for Lung TUmours Using Real-Time Tumour Tracking & Respiratory Gating

NCT03322072 | Active Not Recruiting FDA Device

• 1 other identifier: RRIC 2017-014
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

This is a single arm seamless phase I/II prospective cohort study. Patients with early stage Non-Small Cell Lung Cancer (T1-T2N0M0) or those with a single pulmonary metastasis of a known malignancy (either following radical treatment or systemic therapy) will be offered participation in this study. Participants will have three tumor locator beacons placed with a flexible bronchoscope in the small bronchial airways in proximity (\<3cm) from their lung tumors. These tumor locator beacons will provide real-time positional data and will allow for smaller treatment volumes of Stereotactic Ablative Radiosurgery (SABR) and also allow for a specialized form of treatment delivery known as respiratory gated SABR. This is expected to result in higher precision radiotheapy delivery with less radiotherapy dose to healthy tissues which are in close proximity to the lung tumours.

Conditions

Lung Cancer Stage I; Lung Cancer Stage II; Lung Cancer, Nonsmall Cell; Lung Cancer Recurrent; Lung Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

• Mean within patient difference in PTV volumes

  Mean within patient difference in PTV volumes of standard non-gated SABR treatment compared to PTV volumes of gated SABR using Calypso based PTV margins

  Assessed Immediately prior to RT start

Secondary Outcomes (6)

• Patient self-reported quality of life

  1, 2, and 3 year

• Acute and late toxicity assessment using the Common Terminology Criteria for Adverse Events (CTCAE version 4.0)

  1, 2, and 3 year

• RT doses to Thoracic Organs at Risk

  Assessed Immediately prior to RT start

• Tumour Local Control

  1, 2, and 3 year

• Progression Free Survival

  1,2, and 3 year

Study Arms (1)

Real-Time Position Transponder Beacons

EXPERIMENTAL

Patients in this arm will each be receiving 3 implanted real-time position transponder beacons (Calypso beacons)

Device: Real-Time Position Transponder Beacons

Interventions

Real-Time Position Transponder Beacons DEVICE

The anchored lung tracking beacons are passive electromagnetic transponder beacons which are placed immediately adjacent to a lung tumor using a bronchoscope. Three beacons will be placed in the small airways of the lung adjacent to the target tumor (within 3 cm of the tumor). Each beacon measures 2 mm in diameter and 8 mm in length and consists of a miniature electrical circuit that is encapsulated in a biocompatible glass capsule. Each beacon has an affixed five-legged anchoring system which expands to 5mm diameter once deployed. The Calypso transponder beacon is placed endobronchially using the working channel of a bronchoscope. Navigational bronchoscopy can be used to pre-plan the optimal location for each beacon to be placed within the airways by using a pre-bronchoscopy CT scan.

Real-Time Position Transponder Beacons

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ≥ 18 years of age who is surgically inoperable, or refusing surgical management.
• Tumor criteria (a patient must satisfy one of "a", "b" below to be eligible):
• AJCC 7th edition clinical T1aN0M0, T1bN0M0, or T2aN0M0 (\<4cm) Non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma, or NSCLC Not Otherwise Specified) of the middle or lower lobes of the lung\*;
• A single pulmonary metastasis (\<4cm) of a known primary malignancy of any histology involving the middle or lower lobes of the lung\* (either metastatic failure to a single pulmonary site after primary radical treatment, metastatic progression to a single lung metastasis following palliative chemotherapy, or a single pulmonary metastatic lesion of newly diagnosed stage IV malignancy).
• upper lobe tumors are eligible for trial participation if the tumor has a demonstrated tumor motion of ≥1 cm in any axis (as assessed by fluoroscopy at the time of bronchoscopy).
• Confirmation of malignancy (a patient must satisfy one of "a", "b" below to be eligible):
• Tumors accessible by bronchoscopy, image-guided percutaneous biopsy, or other invasive staging methods require biopsy confirmation of malignancy.
• If a tumor is not amenable to a diagnostic biopsy, evidence of growth of the target tumor on serial imaging scans is necessary prior to enrollment. An increase in SUV of the target tumor on serial PET scans is also acceptable.
• ECOG performance status of 0 to 2.
• Minimum life expectancy of 6 months.
• Deemed fit to undergo bronchoscopy by their participating thoracic surgeon
• Deemed fit to undergo SABR by their participating Radiation Oncologist.
• Respiratory function (a patient must satisfy both "a" and "b" below):
• Minimum FEV1 of 0.8 liters
• Minimum DLCO of 35% predicted.

You may not qualify if:

• Tumors located \< 1cm from the chest wall based on CT imaging.
• Tumors located ≤ 2 cm from the proximal bronchial tree (see figure 7)
• Patients who require supplemental oxygen at rest.
• Patients who are unable to lie flat or still for a minimum of 30 minutes.
• ECOG performance status 3 or 4.
• Evidence of uncontrolled extra-thoracic metastatic disease (based on imaging or clinical findings).
• Proven or suspected intrathoracic lymph node involvement.
• Prior SABR to the target tumor.
• Prior history of idiopathic pulmonary fibrosis, interstitial lung disease, or active collagen vascular disease (systemic lupus erythematosus, Rheumatoid arthritis, or Scleroderma)
• Pregnancy.
• Active pulmonary infection
• Known hypersensitivity to nickel titanium (Nitinol)
• Known Bronchiectasis of the small airways nearest to the tumor

Sponsors & Collaborators

• CancerCare Manitoba: lead
• Varian Medical Systems: collaborator

Study Sites (2)

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Health Sciences Center

Winnipeg, Manitoba, R, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single arm prospective cohort study

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 26, 2017
• Study Start: November 23, 2017
• Primary Completion: January 14, 2025
• Study Completion: January 14, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)