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

Primary Purpose

Solitary Pulmonary Nodule, Bronchial Neoplasms

Status
Terminated
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Radioactive labelling of pulmonary nodules
CT guided radioactive labelling
Electromagnetic guided bronchoscopic radioactive labelling
Sponsored by
Cantonal Hospital of St. Gallen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Solitary Pulmonary Nodule focused on measuring Solitary Pulmonary Nodule, Thoracoscopy, Thoracic Surgery, Video-Assisted, Radioactive Tracers, Radioguided surgery, Handheld-SPECT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cantonal Hospital St.Gallen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CT guided labelling

Electromagnetic bronchoscopic labelling

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

CT labelling
Success rate of CT labelling
CT Labelling complications
complication rate attributable to CT labelling
Successful labeling using electro-magnetically navigated bronchoscopy
Rate of successful labeling using electro-magnetically navigated bronchoscopy
Complications after labeling using electro-magnetically navigated bronchoscopy
Complication rate after labeling using electro-magnetically navigated bronchoscopy

Full Information

First Posted
November 28, 2013
Last Updated
February 1, 2017
Sponsor
Cantonal Hospital of St. Gallen
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1. Study Identification

Unique Protocol Identification Number
NCT02050724
Brief Title
ThoHSpEkt Thoracoscopic Ectomy of Radioactively Marked Pulmonary Nodules With Free-hand SPECT
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Ende of part 1. Only few patients in part 2 enrolled
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital of St. Gallen

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solitary Pulmonary Nodule, Bronchial Neoplasms
Keywords
Solitary Pulmonary Nodule, Thoracoscopy, Thoracic Surgery, Video-Assisted, Radioactive Tracers, Radioguided surgery, Handheld-SPECT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT guided labelling
Arm Type
Experimental
Arm Description
CT guided radioactive labelling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery.
Arm Title
Electromagnetic bronchoscopic labelling
Arm Type
Experimental
Arm Description
Electromagnetic guided bronchoscopic labeling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery.
Intervention Type
Drug
Intervention Name(s)
Radioactive labelling of pulmonary nodules
Other Intervention Name(s)
Tc-99m MAA (Maasol GE)
Intervention Description
Application directly into a pulmonary nodule
Intervention Type
Device
Intervention Name(s)
CT guided radioactive labelling
Other Intervention Name(s)
CT GE (PET-CT Discovery)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Electromagnetic guided bronchoscopic radioactive labelling
Other Intervention Name(s)
iLogic, Firme SuperDimension
Intervention Description
Electromagnetic guided bronchoscopy is a standard procedure. In this study it is used to mark pulmonary nodules.
Primary Outcome Measure Information:
Title
Successful thoracoscopic ectomies
Description
Rate of successful thoracoscopic ectomies (i.e. without reversion to (mini-)thoracotomy and without any complications)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
CT labelling
Description
Success rate of CT labelling
Time Frame
1 day
Title
CT Labelling complications
Description
complication rate attributable to CT labelling
Time Frame
1 day
Title
Successful labeling using electro-magnetically navigated bronchoscopy
Description
Rate of successful labeling using electro-magnetically navigated bronchoscopy
Time Frame
1 day
Title
Complications after labeling using electro-magnetically navigated bronchoscopy
Description
Complication rate after labeling using electro-magnetically navigated bronchoscopy
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age over 18 years Planed thoracoscopic surgery of a pulmonary nodule Informed consent Exclusion Criteria: mental incapacity contraindications for this treatment pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Müller, MD
Organizational Affiliation
Cantonal Hospital St. Gallen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cantonal Hospital St.Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27207315
Citation
Muller J, Putora PM, Schneider T, Zeisel C, Brutsche M, Baty F, Markus A, Kick J. Handheld single photon emission computed tomography (handheld SPECT) navigated video-assisted thoracoscopic surgery of computer tomography-guided radioactively marked pulmonary lesions. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):345-50. doi: 10.1093/icvts/ivw136. Epub 2016 May 20.
Results Reference
derived

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

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