Trials / Terminated
TerminatedNCT02050724
ThoHSpEkt Thoracoscopic Ectomy of Radioactively Marked Pulmonary Nodules With Free-hand SPECT
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.
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Cantonal Hospital of St. Gallen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Radioactive labelling of pulmonary nodules | Application directly into a pulmonary nodule |
| DEVICE | CT guided radioactive labelling | 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. |
| DEVICE | Electromagnetic guided bronchoscopic radioactive labelling | Electromagnetic guided bronchoscopy is a standard procedure. In this study it is used to mark pulmonary nodules. |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2016-12-31
- Completion
- 2016-12-31
- First posted
- 2014-01-31
- Last updated
- 2017-02-02
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT02050724. Inclusion in this directory is not an endorsement.