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

Summary

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.

Timeline

Start

2013-11

Primary completion

2016-12-31

Completion

2016-12-31

Outcome

Outcome not reported

Stopped (Enrollment): “Ende of part 1. Only few patients in part 2 enrolled”

Publications

• 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.

Drugs

Indications