Percutaneous Localization: Open-label Registry of Thoracic Surgery (PLOTS)

• ClinicalTrials.gov Identifier: NCT04066699
• Recruitment Status: Unknown
• First Posted: August 26, 2019
• Last Update Posted: March 30, 2021
• Sponsor: Veran Medical Technologies
• Information provided by (Responsible Party): Veran Medical Technologies

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Lung Lesion(s) Requiring Evaluation; Pulmonary Metastasis; Pulmonary Nodule, Solitary; Peripheral Lung Lesions	Procedure: Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools.

Detailed 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.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 6 Weeks
• Official Title: Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes.
• Actual Study Start Date: October 10, 2019
• Estimated Primary Completion Date: February 2022
• Estimated Study Completion Date: April 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Localization; Electromagnetic navigation (EMN) guided percutaneous localization of suspicious lung lesion(s).	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.; Other Names: SPiN Thoracic Navigation System™; Veran System

Outcome Measures

Primary Outcome Measures :

1. Rate of successful percutaneous localization and removal of PPN. [ Time Frame: Duration of procedure. ]
   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.
2. Collect safety data for localization procedure. [ Time Frame: Duration of procedure. ]

Secondary Outcome Measures :

1. Report localization method and technique. [ Time Frame: Duration of procedure. ]
   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..
2. Collect data on intraoperative percutaneous localization time and duration of total surgical procedure. [ Time Frame: Duration of procedure. ]
   The time of the localization procedure will be recorded. The length of the entire surgical procedure will also be recorded.
3. Record nodule characteristics, including location in the lobe, distance from pleura, distance from surface of skin to target, morphological appearance, solid vs. ground glass etc. [ Time Frame: Duration of procedure. ]
4. Record weight of excised tissue and margin. [ Time Frame: Duration of procedure. ]
5. Report type of surgical resection performed and the resection technique used. [ Time Frame: Duration of procedure. ]
   The surgical resection may include segmentectomy or wedge using the VATS, RATS, or thoracotomy techniques.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

The target subject population includes adult subjects (18 years - 85 years), with small, suspicious lung lesions. Patients with small, indeterminate PPNs that, in the judgment of the thoracic surgeon, based on surgical risk and risk of malignancy, warrant lung resection via a percutaneous localization approach. Data will be collected from study subjects having a PPN between 0.4 cm and 3.2 cm in greatest dimension, that are accessible to percutaneous localization, who consent to and undergo intraoperative dye/wire localization procedure followed by surgical lung resection.

Criteria

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).

Contacts and Locations

Contacts

Contact: Nathan Hunt; 314-659-8500; PLOTS@veranmedical.com

Locations

United States, Colorado

Kaiser Permanente; Recruiting

Lone Tree, Colorado, United States, 80124

Contact: Lanny Dunham, MD

United States, Maine

Northern Light Eastern Maine Medical Center; Recruiting

Bangor, Maine, United States, 04401

Contact: Jawad Latif, MD

United States, New York

Vassar Brothers Medical Center; Recruiting

Poughkeepsie, New York, United States, 12601

Contact: Faiz Bhora, MD

United States, North Carolina

University of North Carolina at Chapel Hill; Recruiting

Chapel Hill, North Carolina, United States, 27599

Contact: Jason Long, MD

United States, Texas

Houston Methodist Hospital; Recruiting

Houston, Texas, United States, 77030

Contact: Min Kim, MD

Sponsors and Collaborators

Veran Medical Technologies

Investigators

• Principal Investigator: Faiz Bhora, MD; Vassar Brothers Medical Center

More Information

Publications:

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.

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.

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.

• Responsible Party: Veran Medical Technologies
• ClinicalTrials.gov Identifier: NCT04066699
• Other Study ID Numbers: VMT-01-003
• First Posted: August 26, 2019
• Last Update Posted: March 30, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Veran Medical Technologies:

Surgical Lung Resection; Percutaneous Localization; Electromagnetic Navigation; Transthoracic Localization; Peripheral Pulmonary Nodule(s)

Additional relevant MeSH terms:

Multiple Pulmonary Nodules; Solitary Pulmonary Nodule; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases