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

Cantonal Hospital of St. Gallen

Status and phase: Terminated; Phase 2

Conditions: Solitary Pulmonary Nodule; Bronchial Neoplasms

Treatments: Drug: Radioactive labelling of pulmonary nodules; Device: Electromagnetic guided bronchoscopic radioactive labelling; Device: CT guided radioactive labelling

Study type: Interventional

Funder types: Other

Identifiers

NCT02050724

CTU 12/048

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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11 participants in 2 patient groups

CT guided labelling

Experimental group

Description:

CT guided radioactive labelling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery.

Treatment:

Device: CT guided radioactive labelling

Drug: Radioactive labelling of pulmonary nodules

Electromagnetic bronchoscopic labelling

Experimental group

Description:

Electromagnetic guided bronchoscopic labeling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery.

Treatment:

Device: Electromagnetic guided bronchoscopic radioactive labelling

Drug: Radioactive labelling of pulmonary nodules