ThoHSpEkt Thoracoscopic Ectomy of Radioactively Marked Pulmonary Nodules With Free-hand SPECT

Study Overview
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Brief Summary
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Title ThoHSpEkt Study Design Pilot Study concerning the technical operative methods and a phase II study concerning the radiopharmaceutical (therapeutic-explorative study with an approved drug in a new indication) Location Kantonsspital St.Gallen Aim Proof of feasibility of thoracoscopic ectomy of radioactively marked pulmonary nodules with the help of free-hand SPECT. Background In the Cantonal Hospital of St.Gallen an average of 30 - 40 patients will be operated with thoracoscopic ectomy for a pulmonary nodule. When localisation of the nodule is not possible a switch to minithoracotomy is performed. Study intervention Marking of pulmonary nodules with radioactivity. Free-hand SPECT guided surgery Risks Risks of bronchoscopic or CT-intervention Radiation risk (minimal) Rational for patient number 10 patients for each group are enough to prove the feasibility, to manage difficulties and to record complications Duration approximately 24 months.

Official Title
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Thorakoskopische Handheld-SPECT Gesteuerte Ektomie Von Radioaktiv-markierten Pulmonalen Rundherden. Proof of Feasibility of Thoracoscopic Ectomy of Radioactively Marked Pulmonary Nodules With the Help of Free-hand SPECT.

Conditions
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Solitary Pulmonary Nodule, Bronchial Neoplasms

Intervention / Treatment
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* Drug: Radioactive labelling of pulmonary nodules
* Device: CT guided radioactive labelling
* Device: Electromagnetic guided bronchoscopic radioactive labelling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 18 years Planed thoracoscopic surgery of a pulmonary nodule Informed consent Exclusion Criteria: mental incapacity contraindications for this treatment pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT guided labelling<br>CT guided radioactive labelling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery. | Drug: Radioactive labelling of pulmonary nodules<br>* Application directly into a pulmonary nodule<br>* Other names: Tc-99m MAA (Maasol GE);Device: CT guided radioactive labelling<br>* CT guided puncture is a standard procedure in radiology. In this study it is used to mark pulmonary nodules for the following thoracoscopic surgery, done with a handheld-SPECT device.<br>* Other names: CT GE (PET-CT Discovery);|
| Experimental: Electromagnetic bronchoscopic labelling<br>Electromagnetic guided bronchoscopic labeling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery. | Drug: Radioactive labelling of pulmonary nodules<br>* Application directly into a pulmonary nodule<br>* Other names: Tc-99m MAA (Maasol GE);Device: Electromagnetic guided bronchoscopic radioactive labelling<br>* Electromagnetic guided bronchoscopy is a standard procedure. In this study it is used to mark pulmonary nodules.<br>* Other names: iLogic, Firme SuperDimension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful thoracoscopic ectomies | Rate of successful thoracoscopic ectomies (i.e. without reversion to (mini-)thoracotomy and without any complications) | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT labelling | Success rate of CT labelling | 1 day | 
| CT Labelling complications | complication rate attributable to CT labelling | 1 day | 
| Successful labeling using electro-magnetically navigated bronchoscopy | Rate of successful labeling using electro-magnetically navigated bronchoscopy | 1 day | 
| Complications after labeling using electro-magnetically navigated bronchoscopy | Complication rate after labeling using electro-magnetically navigated bronchoscopy | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solitary Pulmonary Nodule, Thoracoscopy, Thoracic Surgery, Video-Assisted, Radioactive Tracers, Radioguided surgery, Handheld-SPECT