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

Phase 2

Terminated

• Conditions: Solitary Pulmonary Nodule; Bronchial Neoplasms
• Interventions: Drug: Radioactive labelling of pulmonary nodules; Device: CT guided radioactive labelling; Device: Electromagnetic guided bronchoscopic radioactive labelling

• Registration Number: NCT02050724
• Lead Sponsor: Cantonal Hospital of St. Gallen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-28
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-31
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• age over 18 years
• Planed thoracoscopic surgery of a pulmonary nodule
• Informed consent

Exclusion Criteria

• mental incapacity
• contraindications for this treatment
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CT guided labelling	CT guided radioactive labelling	CT guided radioactive labelling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery.
Electromagnetic bronchoscopic labelling	Radioactive labelling of pulmonary nodules	Electromagnetic guided bronchoscopic labeling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery.
CT guided labelling	Radioactive labelling of pulmonary nodules	CT guided radioactive labelling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery.
Electromagnetic bronchoscopic labelling	Electromagnetic guided bronchoscopic radioactive labelling	Electromagnetic guided bronchoscopic labeling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery.

Primary Outcome Measures

Name	Time	Method
Successful thoracoscopic ectomies	1 week	Rate of successful thoracoscopic ectomies (i.e. without reversion to (mini-)thoracotomy and without any complications)

Secondary Outcome Measures

Name	Time	Method
CT labelling	1 day	Success rate of CT labelling
CT Labelling complications	1 day	complication rate attributable to CT labelling
Successful labeling using electro-magnetically navigated bronchoscopy	1 day	Rate of successful labeling using electro-magnetically navigated bronchoscopy
Complications after labeling using electro-magnetically navigated bronchoscopy	1 day	Complication rate after labeling using electro-magnetically navigated bronchoscopy

Trial Locations

Locations (1)

Cantonal Hospital St.Gallen; 🇨🇭 St. Gallen, Switzerland