NCT02050724

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

3.2 years

First QC Date

November 28, 2013

Last Update Submit

February 1, 2017

Conditions

Solitary Pulmonary NoduleBronchial Neoplasms

Keywords

Solitary Pulmonary NoduleThoracoscopyThoracic SurgeryVideo-AssistedRadioactive TracersRadioguided surgeryHandheld-SPECT

Outcome Measures

Primary Outcomes (1)

  • Successful thoracoscopic ectomies

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

    1 week

Secondary Outcomes (4)

  • CT labelling

    1 day

  • CT Labelling complications

    1 day

  • Successful labeling using electro-magnetically navigated bronchoscopy

    1 day

  • Complications after labeling using electro-magnetically navigated bronchoscopy

    1 day

Study Arms (2)

CT guided labelling

EXPERIMENTAL

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

Drug: Radioactive labelling of pulmonary nodulesDevice: CT guided radioactive labelling

Electromagnetic bronchoscopic labelling

EXPERIMENTAL

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

Drug: Radioactive labelling of pulmonary nodulesDevice: Electromagnetic guided bronchoscopic radioactive labelling

Interventions

Radioactive labelling of pulmonary nodulesDRUG

Application directly into a pulmonary nodule

Also known as: Tc-99m MAA (Maasol GE)
CT guided labellingElectromagnetic bronchoscopic labelling
CT guided radioactive labellingDEVICE

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.

Also known as: CT GE (PET-CT Discovery)
CT guided labelling
Electromagnetic guided bronchoscopic radioactive labellingDEVICE

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

Also known as: iLogic, Firme SuperDimension
Electromagnetic bronchoscopic labelling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • mental incapacity
  • contraindications for this treatment
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cantonal Hospital St.Gallen

Sankt Gallen, 9007, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 27207315DERIVED

MeSH Terms

Conditions

Solitary Pulmonary NoduleBronchial Neoplasms

Interventions

Technetium Tc 99m Aggregated Albumin

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsBronchial Diseases

Intervention Hierarchy (Ancestors)

Organotechnetium CompoundsOrganometallic CompoundsOrganic ChemicalsAlbuminsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Joachim Müller, MD

    Cantonal Hospital of St. Gallen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

November 28, 2013

First Posted

January 31, 2014

Study Start

November 1, 2013

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

February 2, 2017

Record last verified: 2017-02

Locations

CH(1)