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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02050724

Acronym

ThoHSpEkt

Enrollment

Registered

2014-01-31

Start date

2013-11-30

Completion date

2016-12-31

Last updated

2017-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Neoplasms, Solitary Pulmonary Nodule

Keywords

Solitary Pulmonary Nodule, Thoracoscopy, Thoracic Surgery, Video-Assisted, Radioactive Tracers, Radioguided surgery, Handheld-SPECT

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.

Interventions

DRUGRadioactive labelling of pulmonary nodules

Application directly into a pulmonary nodule

DEVICECT 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.

DEVICEElectromagnetic guided bronchoscopic radioactive labelling

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* mental incapacity * contraindications for this treatment * pregnancy

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026