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NCT02050724 Clinical Trial

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

Solitary Pulmonary Nodule Clinical Trial

— ThoHSpEkt  

Official title:
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.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02050724
Other study ID # CTU 12/048
Secondary ID
Status Terminated
Phase Phase 2
First received November 28, 2013
Last updated February 1, 2017
Start date November 2013
Est. completion date December 31, 2016

Study information
Verified date February 2017
Source Cantonal Hospital of St. Gallen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 11
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.
• Electromagnetic guided bronchoscopic radioactive labelling
Electromagnetic guided bronchoscopy is a standard procedure. In this study it is used to mark pulmonary nodules.

Locations
Country Name City State
Switzerland Cantonal Hospital St.Gallen St. Gallen

Sponsors (1)
Lead Sponsor Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Successful thoracoscopic ectomies Rate of successful thoracoscopic ectomies (i.e. without reversion to (mini-)thoracotomy and without any complications) 1 week
Secondary CT labelling Success rate of CT labelling 1 day
Secondary CT Labelling complications complication rate attributable to CT labelling 1 day
Secondary Successful labeling using electro-magnetically navigated bronchoscopy Rate of successful labeling using electro-magnetically navigated bronchoscopy 1 day
Secondary Complications after labeling using electro-magnetically navigated bronchoscopy Complication rate after labeling using electro-magnetically navigated bronchoscopy 1 day
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