Solitary Pulmonary NodulePhase 2ThoHSpEktNCT02050724
ThoHSpEkt Thoracoscopic Ectomy of Radioactively Marked Pulmonary Nodules With Free-hand SPECT
A Phase 2 study testing Radioactive labelling of pulmonary nodules, CT guided radioactive labelling and Electromagnetic guided bronchoscopic radioactive labelling in people with Solitary Pulmonary Nodule and Bronchial Neoplasms, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solitary Pulmonary Nodule, Bronchial Neoplasms
- What is being tested?
- Radioactive labelling of pulmonary nodules, CT guided radioactive labelling and Electromagnetic guided bronchoscopic radioactive labelling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2013to 31 Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18 years
- Planed thoracoscopic surgery of a pulmonary nodule
- Informed consent
Who cannot join
- mental incapacity
- contraindications for this treatment
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
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)
Read more
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.
- Conditions
- Solitary Pulmonary Nodule, Bronchial Neoplasms
- Being tested
- Radioactive labelling of pulmonary nodules, CT guided radioactive labelling, Electromagnetic guided bronchoscopic radioactive labelling
- Keywords
- Solitary Pulmonary Nodule, Thoracoscopy, Thoracic Surgery, Video-Assisted, Radioactive Tracers, Radioguided surgery, Handheld-SPECT
- Medical subject headings
- Solitary Pulmonary Nodule, Bronchial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioactive labelling of pulmonary nodulesDrug
Also called Tc-99m MAA (Maasol GE)
Application directly into a pulmonary nodule
CT guided radioactive labellingDevice
Also called CT GE (PET-CT Discovery)
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.
Electromagnetic guided bronchoscopic radioactive labellingDevice
Also called iLogic, Firme SuperDimension
Electromagnetic guided bronchoscopy is a standard procedure. In this study it is used to mark pulmonary nodules.
| Study group | Role | What they receive |
|---|---|---|
| CT guided labelling | Experimental | CT guided radioactive labelling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery. Receives: Drug: Radioactive labelling of pulmonary nodules; Device: CT guided radioactive labelling |
| Electromagnetic bronchoscopic labelling | Experimental | Electromagnetic guided bronchoscopic labeling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery. Receives: Drug: Radioactive labelling of pulmonary nodules; Device: Electromagnetic guided bronchoscopic radioactive labelling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful thoracoscopic ectomies
Rate of successful thoracoscopic ectomies (i.e. without reversion to (mini-)thoracotomy and without any complications)
Measured: 1 week
Secondary outcomes (4)
CT labelling
Success rate of CT labelling
Measured: 1 day
CT Labelling complications
complication rate attributable to CT labelling
Measured: 1 day
Successful labeling using electro-magnetically navigated bronchoscopy
Rate of successful labeling using electro-magnetically navigated bronchoscopy
Measured: 1 day
Complications after labeling using electro-magnetically navigated bronchoscopy
Complication rate after labeling using electro-magnetically navigated bronchoscopy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startNov 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Why it stopped: Ende of part 1. Only few patients in part 2 enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solitary Pulmonary NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Müller, Cantonal Hospital of St. Gallen
- Investigators
- Joachim Müller, MD, Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050724
- Sponsor's protocol ID
- CTU 12/048
- Acronym
- ThoHSpEkt
- Status last verified
- Feb 2017
- First submitted
- 28 Nov 2013
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27207315
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02050724
- Acronym / sponsor ID
- ThoHSpEkt / CTU 12/048
- Conditions
- Solitary Pulmonary Nodule, Bronchial Neoplasms
- Keywords
- Solitary Pulmonary Nodule, Thoracoscopy, Thoracic Surgery, Video-Assisted, Radioactive Tracers, Radioguided surgery, Handheld-SPECT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Ende of part 1. Only few patients in part 2 enrolled
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT guided labelling | Experimental | Drug: Radioactive labelling of pulmonary nodules, Device: CT guided radioactive labellingCT guided radioactive labelling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery. |
| Electromagnetic bronchoscopic labelling | Experimental | Drug: Radioactive labelling of pulmonary nodules, Device: Electromagnetic guided bronchoscopic radioactive labellingElectromagnetic guided bronchoscopic labeling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age over 18 years
- Planed thoracoscopic surgery of a pulmonary nodule
- Informed consent
Key exclusion criteria (3 listed)
- mental incapacity
- contraindications for this treatment
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radioactive labelling of pulmonary nodulesAlso: Tc-99m MAA (Maasol GE)Application directly into a pulmonary nodule | Drug | CT guided labelling, Electromagnetic bronchoscopic labelling |
| CT guided radioactive labellingAlso: CT GE (PET-CT Discovery)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. | Device | CT guided labelling |
| Electromagnetic guided bronchoscopic radioactive labellingAlso: iLogic, Firme SuperDimensionElectromagnetic guided bronchoscopy is a standard procedure. In this study it is used to mark pulmonary nodules. | Device | Electromagnetic bronchoscopic labelling |
Primary outcome
Successful thoracoscopic ectomies
Time frame: 1 week
Rate of successful thoracoscopic ectomies (i.e. without reversion to (mini-)thoracotomy and without any complications)
4 secondary outcomes
CT labelling
Time frame: 1 day
CT Labelling complications
Time frame: 1 day
Successful labeling using electro-magnetically navigated bronchoscopy
Time frame: 1 day
Complications after labeling using electro-magnetically navigated bronchoscopy
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Ende of part 1. Only few patients in part 2 enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Derived from this study: PubMed 27207315Muller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Müller, MD principal investigator
Cantonal Hospital of St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radioactive labelling of pulmonary nodules, CT guided radioactive labelling and Electromagnetic guided bronchoscopic radioactive labelling in people with Solitary Pulmonary Nodule and Bronchial Neoplasms, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Ende of part 1. Only few patients in part 2 enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful thoracoscopic ectomies (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02050724, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.