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

Sponsor
Cantonal Hospital of St. Gallen (Other)
Overall Status
Terminated
CT.gov ID
NCT02050724
Collaborator
(none)
11
Enrollment
1
Location
2
Arms
38
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Radioactive labelling of pulmonary nodules
  • Device: CT guided radioactive labelling
  • Device: Electromagnetic guided bronchoscopic radioactive labelling
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Investigator)
Primary Purpose:
Diagnostic
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.
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Dec 31, 2016
Actual Study Completion Date :
Dec 31, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Successful thoracoscopic ectomies [1 week]

      Rate of successful thoracoscopic ectomies (i.e. without reversion to (mini-)thoracotomy and without any complications)

    Secondary Outcome Measures

    1. CT labelling [1 day]

      Success rate of CT labelling

    2. CT Labelling complications [1 day]

      complication rate attributable to CT labelling

    3. Successful labeling using electro-magnetically navigated bronchoscopy [1 day]

      Rate of successful labeling using electro-magnetically navigated bronchoscopy

    4. Complications after labeling using electro-magnetically navigated bronchoscopy [1 day]

      Complication rate after labeling using electro-magnetically navigated bronchoscopy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age over 18 years

    • Planed thoracoscopic surgery of a pulmonary nodule

    • Informed consent

    Exclusion Criteria:

    • mental incapacity

    • contraindications for this treatment

    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cantonal Hospital St.Gallen St. Gallen Switzerland 9007

    Sponsors and Collaborators

    • Cantonal Hospital of St. Gallen

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Joachim Müller, Head of Department, Cantonal Hospital of St. Gallen
    ClinicalTrials.gov Identifier:
    NCT02050724
    Other Study ID Numbers:
    • CTU 12/048
    First Posted:
    Jan 31, 2014
    Last Update Posted:
    Feb 2, 2017
    Last Verified:
    Feb 1, 2017
    Keywords provided by Joachim Müller, Head of Department, Cantonal Hospital of St. Gallen
    Solitary Pulmonary Nodule
    Thoracoscopy
    Thoracic Surgery
    Video-Assisted
    Radioactive Tracers
    Radioguided surgery
    Handheld-SPECT
    Additional relevant MeSH terms:
    Multiple Pulmonary Nodules
    Bronchial Neoplasms
    Solitary Pulmonary Nodule
    Technetium Tc 99m Aggregated Albumin

    Study Results

    No Results Posted as of Feb 2, 2017