NCT05545085: PORTION-I

Thoracoscopic Laser Speckle Contrast Imaging for Segment Resections

Status unknown Last updated 9 January 2023

What this trial tests

trial testing Laser Speckle Contrast Imaging using the PerfusiX-Imaging Device in Pulmonary Cancer in 10 participants. Status unknown.

Timeline

1 November 2022

Primary endpoint
1 April 2023

1 September 2023

Quick facts

Lead sponsor	Frisius Medisch Centrum
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	10
Start date	1 November 2022
Primary completion	1 April 2023
Estimated completion	1 September 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• Laser Speckle Contrast Imaging using the PerfusiX-Imaging Device

Conditions studied

• Pulmonary Cancer — all drugs for Pulmonary Cancer →

Sponsor

Frisius Medisch Centrum — full company profile →

Who can join

18 and older, any sex, with Pulmonary Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale Lung cancer remains to be the leading cause of cancer-related deaths worldwide1. The current standard-of-care for small lung cancer is a total lobectomy. Albeit effective with respect to the radical excision of the tumour, the substantial loss in lung tissue may be clinically relevant, especially in combination with frequently co-existing lung diseases. Thoracoscopic segmentectomy is a combination of adequate oncological resection with lung-tissue-sparing properties and is being increasingly used because of its several advantages compared with lobar resections. By defining the segment that has to be excised pre-operatively, the key to successful pulmonary segmentectomy is to subsequently intraoperatively recognize the intersegmental planes correctly. The conventional and most common method uses a ventilation method (inflation/deflation technique). With the increasing availability of endoscopic imaging systems, indocyanine green (ICG) fluorescence imaging is a more advanced method to determine intersegmental planes. The major limitation is the use of an exogenous contrast agent. After injection, the ICG only has very limited "imaging time window" (minutes) in which the images can be used to determine the intersegmental planes. Furthermore, the use of dye limits repeatability of measurements due to rest ICG, the extra operating room time required for the injection, wash-in and wash-out of the dye as well as change of camera settings. These limitations leave room for new technologies and improvements. The investigators hypothesized that an endoscopic laser speckle imaging device could overcome the limitations of ICG-fluorescence imaging and could thus be a very useful addition in intersegmental plane detection. PerfusiX-Imaging (LIMIS Development BV, Leeuwarden, The Netherlands) is such an endoscopic laser speckle contrast imager that has been developed in the Medical Centre Leeuwarden since 2014. LSCI has never been used to identify intersegmental planes, however, based on the similarities between LSCI and ICG-fluorescence, this novel imaging approach is thought to be effective and potentially could be used as a standard-of-care.

Objectives In this trial the investigators will study the utility of PerfusiX-Imaging for the identification of intersegmental planes during thoracoscopic segmentectomy.

Study design The current study is a prospective, observational single-centre study in the Medical Center Leeuwarden.

Study population A total of 10 patients undergoing an upper left or right lobectomy. Patient related study procedures All patients will undergo the standard-of-care program which includes perfusion assessment by ICG-fluorescence imaging. In addition to this standard-of-care, 2D-perfusion maps will be generated from images taken with PerfusiX-Imaging (LIMIS Development BV, Leeuwarden, The Netherlands). Not related to the patient, the PerfusiX-Imaging images will be shown to the surgeon postoperatively and peroperative questionnaires will be filled regarding the standard-of-care perfusion assessment.

Study parameters/endpoints Due to the explorative character of this study, there is no formal hierarchy in the respective endpoints of this study. In this, all endpoints will add to the overall assessment of the feasibility of the PerfusiX-imaging derived visual feedback for detecting interlobar and intersegmental planes in lung tissue. The investigators will register whether it was possible to detect the intersegmental plane. Subsequently, compare the difference in location of both the interlobar and intersegmental planes as derived from visual feedback from the PerfusiX-imaging system is compared, with images derived from ICG imaging and the surgical eye. During the procedure, the time needed to generate and acquire the visual feedback from the PerfusiX-imaging system will be determined. The investigators will also determine the interpretability of the visual feedback from the PerfusiX-imaging system by users (surgeons). In addition, the investigators will determine Laser Speckle Perfusion Unit (LSPU) cut-off values of PerfusiX-imaging in lung tissue with the best sensitivity and specificity for the indication of level of tissue perfusion.

Burden, risk and benefit to participation Burden Not applicable. Risks Not applicable. Benefit Not applicable.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.