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

February 1, 2017 updated by: Joachim Müller, Cantonal Hospital of St. Gallen

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • St. Gallen, Switzerland, 9007
        • Cantonal Hospital St.Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT guided labelling
CT guided radioactive labelling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery.
Drug: Radioactive labelling of pulmonary nodules
Application directly into a pulmonary nodule
Other Names:
  • Tc-99m MAA (Maasol GE)
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.
Other Names:
  • CT GE (PET-CT Discovery)
Experimental: Electromagnetic bronchoscopic labelling
Electromagnetic guided bronchoscopic labeling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery.
Drug: Radioactive labelling of pulmonary nodules
Application directly into a pulmonary nodule
Other Names:
  • Tc-99m MAA (Maasol GE)
Device: Electromagnetic guided bronchoscopic radioactive labelling
Electromagnetic guided bronchoscopy is a standard procedure. In this study it is used to mark pulmonary nodules.
Other Names:
  • iLogic, Firme SuperDimension

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CT labelling
Time Frame: 1 day
Success rate of CT labelling
1 day
CT Labelling complications
Time Frame: 1 day
complication rate attributable to CT labelling
1 day
Successful labeling using electro-magnetically navigated bronchoscopy
Time Frame: 1 day
Rate of successful labeling using electro-magnetically navigated bronchoscopy
1 day
Complications after labeling using electro-magnetically navigated bronchoscopy
Time Frame: 1 day
Complication rate after labeling using electro-magnetically navigated bronchoscopy
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hospital of St. Gallen

Investigators

  • Principal Investigator: Joachim Müller, MD, Cantonal Hospital St. Gallen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

November 28, 2013

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTU 12/048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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