Percutaneous Localization: Open-label Registry of Thoracic Surgery

Pulmonary Nodule, Solitary Clinical Trial

— PLOTS  

Official title:

Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04066699
• Other study ID #: VMT-01-003
• Status: Completed
• Start date: October 10, 2019
• Est. completion date: February 9, 2023

Study information

• Verified date: May 2024
• Source: Veran Medical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The objectives of this study are to evaluate intraoperative percutaneous lung lesion marking assisted by electromagnetic guided percutaneous navigation and related tools.

Description:

The Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection:

a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes (PLOTS) registry is aimed at developing a high quality set of data regarding intraoperative percutaneous localization of peripheral pulmonary nodules (PPNs), and then identifying and promulgating efficient, evidence-based best practices for this technique. The resection procedure itself is standard of care and follows the investigator's standard protocol.

Successful localization of PPNs is a challenge involving multiple factors, beginning with the subjects' health, lung function and also factors specific to the nodule including location within the lung, size, distance from the lung surface, whether solid or ground glass and proximity to a fissure. Hard to see or palpate nodules are currently localized with dye and/or hook wires or fiducials, either endoscopically or percutaneously. Successful, large, prospective studies have not been reported using modern electro-magnetic navigation (EMN)-guided percutaneous intraoperative localization, and different techniques (dye vs. fiducial vs. hook wire etc.) have not been broadly evaluated. It is for these reasons that the different localization techniques used with EMN-guided percutaneous localization will be collected for patients having a suspicious nodule and who undergo percutaneous intra-operative localization and immediate resection.

This registry aims to record the localization techniques used by thoracic surgeons and IP/surgical teams to identify PPNs using the SPiN Thoracic Navigation System™ in the hands of trained physicians. The objectives of this study will be to accomplish the primary and secondary objectives listed below, and to observe localization in a real world context of pulmonary resection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 9, 2023
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject's physician and/or thoracic surgeon have deemed/has deemed that the surgical removal of the PPN is appropriate.

• A clinical decision has been made to use the SPiN Thoracic Navigation System™.

• Subject is at least 18 years of age at time of study entry.

• Subject is able to read, understand, and voluntarily sign the IRB-approved informed consent document prior to the performance of any study-specific procedures. IRB- approved translation may be used if indicated. Reasonable accommodation of visually impaired subjects will be allowed.

• Subject is able to tolerate general anesthesia.

• Subject has a target nodule between 0.4 cm and 3.2 cm in greatest dimension;

• The target nodule is in a location that is accessible for percutaneous localization in the judgement of the surgeon.

Exclusion Criteria:

• Subjects with any other concomitant treatment or medical condition that, in the opinion of the clinician, would render peripheral nodule resection more hazardous than beneficial.

• Subject is pregnant.

• Pulmonary nodule is greater than 3.2 cm.

• Subjects with significant coagulopathy having INR > 2.0 or PTT > 2x normal.

• Subject is unable to tolerate general anesthesia.

• Obese subject, impacting percutaneous access (BMI > 50).

Related Conditions & MeSH terms

• Lung Lesion(s) Requiring Evaluation
• Multiple Pulmonary Nodules
• Peripheral Lung Lesions
• Pulmonary Metastasis
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Intervention

Procedure:
• Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools.
Transthoracic localization of suspicious lung lesion(s) in preparation for subsequent resection.

Locations

Country	Name	City	State
United States	Northern Light Eastern Maine Medical Center	Bangor	Maine
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Houston Methodist Hospital	Houston	Texas
United States	Kaiser Permanente	Lone Tree	Colorado
United States	Vassar Brothers Medical Center	Poughkeepsie	New York

Sponsors (1)

Lead Sponsor	Collaborator
Veran Medical Technologies

Country where clinical trial is conducted

United States, 

References & Publications (3)

Mallow C, Lee H, Oberg C, Thiboutot J, Akulian J, Burks AC, Luna B, Benzaquen S, Batra H, Cardenas-Garcia J, Toth J, Heidecker J, Belanger A, McClune J, Osman U, Lakshminarayanan V, Pastis N, Silvestri G, Chen A, Yarmus L. Safety and diagnostic performance of pulmonologists performing electromagnetic guided percutaneous lung biopsy (SPiNperc). Respirology. 2019 May;24(5):453-458. doi: 10.1111/resp.13471. Epub 2019 Jan 24. — View Citation

Semaan RW, Lerner AD, Lee HJ, Feller-Kopman D, Yarmus LB. Electromagnetic Guidance for the Diagnosis of Pulmonary Nodules: Don't Put the Nail in the Coffin. Am J Respir Crit Care Med. 2016 Jul 1;194(1):121. doi: 10.1164/rccm.201602-0243LE. No abstract available. — View Citation

Thiboutot J, Lee HJ, Silvestri GA, Chen A, Wahidi MM, Gilbert CR, Pastis NJ, Los J, Barriere AM, Mallow C, Salwen B, Dinga MJ, Flenaugh EL, Akulian JA, Semaan R, Yarmus LB. Study Design and Rationale: A Multicenter, Prospective Trial of Electromagnetic Bronchoscopic and Electromagnetic Transthoracic Navigational Approaches for the Biopsy of Peripheral Pulmonary Nodules (ALL IN ONE Trial). Contemp Clin Trials. 2018 Aug;71:88-95. doi: 10.1016/j.cct.2018.06.007. Epub 2018 Jun 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful percutaneous localization and removal of PPN.	Successful percutaneous localization of PPN defined as the percentage of subjects in whom the nodule is successfully localized and removed in the first resected specimen.	Duration of procedure.
Primary	Safety of the localization procedure.	Safety data, including instances of adverse events and device deficiencies, will be collected.	Duration of procedure.
Secondary	Localization method and technique.	Details regarding the localization technique will be collected, including the materials used. If dye (methylene blue, ICG etc.) is used the volume will be collected. Other materials include microcoils, hook wires, etc..	Duration of procedure.
Secondary	Intraoperative percutaneous localization time and duration of total surgical procedure.	The time of the localization procedure will be recorded. The length of the entire surgical procedure will also be recorded.	Duration of procedure.
Secondary	Nodule characteristics, including location in the lobe, distance from pleura, distance from surface of skin to target, morphological appearance, solid vs. ground glass etc.	Details regarding nodule characteristics - solid, semisolid, groundglass; location in relation to anatomical markers and position; size; presence of spiculation - will be collected.	Duration of procedure.
Secondary	Weight of excised tissue and margin.	The weight (in grams) of excised tissue will be recorded, as well as the measurement of the included margin.	Duration of procedure.
Secondary	Type of surgical resection performed and the resection technique used.	The surgical resection may include segmentectomy or wedge using the VATS, RATS, or thoracotomy techniques.	Duration of procedure.