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Ende of part 1. Only few patients in part 2 enrolled
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT guided labelling | Experimental | CT guided radioactive labelling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery. |
|
| Electromagnetic bronchoscopic labelling | Experimental | Electromagnetic guided bronchoscopic labeling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radioactive labelling of pulmonary nodules | Drug | Application directly into a pulmonary nodule |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CT labelling | Success rate of CT labelling | 1 day |
| CT Labelling complications | complication rate attributable to CT labelling | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joachim Müller, MD | Cantonal Hospital of St. Gallen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cantonal Hospital St.Gallen | Sankt Gallen | 9007 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27207315 | Derived | Muller J, Putora PM, Schneider T, Zeisel C, Brutsche M, Baty F, Markus A, Kick J. Handheld single photon emission computed tomography (handheld SPECT) navigated video-assisted thoracoscopic surgery of computer tomography-guided radioactively marked pulmonary lesions. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):345-50. doi: 10.1093/icvts/ivw136. Epub 2016 May 20. |
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|
| CT guided radioactive labelling | Device | 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. |
|
|
| Electromagnetic guided bronchoscopic radioactive labelling | Device | Electromagnetic guided bronchoscopy is a standard procedure. In this study it is used to mark pulmonary nodules. |
|
|
| 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 |
| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| D001984 | Bronchial Neoplasms |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D013668 | Technetium Tc 99m Aggregated Albumin |
| ID | Term |
|---|---|
| D015609 | Organotechnetium Compounds |
| D009942 | Organometallic Compounds |
| D009930 | Organic Chemicals |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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