Pulmonary EmbolismPhase 3NCT01458639
Compare Technegas Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging for Pulmonary Embolism
A Phase 3 study testing Technegas V SPECT imaging and Xenon-133 Ventilation Planar imaging in people with Pulmonary Embolism, run by Cyclomedica Australia PTY Limited at 2 sites in United States.
Trial summary
Phase 3 within-subject trial of Technegas V/Q SPECT and Tc-99m macro-aggregated albumin (MAA) imaging compared to Xenon-133 V/Q planar and Tc-99m macroaggregate of albumin (MAA) imaging for the diagnosis of Pulmonary Embolism (PE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Technegas V SPECT imaging and Xenon-133 Ventilation Planar imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to Jun 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects will be enrolled in Cohort 1 if they meet the following requirements:
- Male or female, at least 18 years of age.
- Suspected of having PE and be a candidate for Xe-133 V/Q imaging.
- Willing and able to provide informed consent.
- Stable and able to undergo Xe-133 planar imaging, Technegas SPECT imaging, and planar/SPECT perfusion imaging and complete follow-up procedures.
- Willing and agree to complete study procedures, including follow-up safety assessments.
Show all 14Show fewer
- Using adequate birth control, if female and fertile.
- If female, has a negative urine or serum pregnancy test.
- Agrees to return for a 24-hour and 30 day follow-up safety assessment.
- Subjects will be enrolled in Cohort 2 if they meet the above criteria AND subject is likely to have pulmonary embolism based on one or more of the following:
- Wells Score of 7 or greater. Subjects with a Wells Score less than 7 may be enrolled in Cohort 2 if there is agreement between the investigator and the medical monitor that the subject is at high risk for PE.
- An abnormal D-dimer test.
- Positive Doppler ultrasound for DVT.
- CTA is positive for PE within 24 hours of this imaging study.
Who cannot join
- Subject
- Has undergone imaging with Iodine-131 (I-131) within 30 days, Thallium-201 (Tl-201) or Indium-111 (In-111) within 10 days, Fluorine 18 (F-18) within 24 hours, or any other radiopharmaceutical not otherwise specified within 72 hours of this imaging study.
- Has previously undergone an imaging study with a Tc-99m agent, within 48 hours of this imaging study.
- Is a pregnant or lactating female.
- Has received Technegas in the past.
- Was previously enrolled in another investigational study or received an investigational drug within 30 days prior to dosing.
- Is hemodynamically unstable.
- Has received therapeutic dose of low molecular weight or unfractionated heparin within 24 hours prior to dosing or Tissue Plasminogen Activator (tPA) within 4 hours prior to dosing or has received treatment for PE between the time of a positive CTA, if performed, and Technegas V/Q SPECT imaging.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University Medical Center
New York, New York, 10032
Barnes-Jewish Hospital, Washington University
St Louis, Missouri, 63110
About this study
Official title: A Comparison of Technegas® Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging in Subjects Being Evaluated for Pulmonary Embolism
Phase 3 within-subject trial of Technegas V/Q SPECT and Tc-99m macro-aggregated albumin (MAA) imaging compared to Xenon-133 V/Q planar and Tc-99m macroaggregate of albumin (MAA) imaging for the diagnosis of Pulmonary Embolism (PE).
Read the detailed description
This is a Phase 3 within-subject trial of Technegas Ventilation SPECT and Tc-99m MAA perfusion imaging compared to xenon (Xe-133) Ventilation Planar and Tc-99m MAA perfusion imaging for the diagnosis of PE. Diagnosis of PE provided by review of the subjects' documented clinical information after 30 days of follow-up. Primary assessments of efficacy will be based on an independent blind reads of the Technegas V/Q SPECT images by three different readers and the independent blind reads of Xe 133 V/Q planar images by three different readers.
- Conditions
- Pulmonary Embolism
- Being tested
- Technegas V SPECT imaging, Xenon-133 Ventilation Planar imaging
- Keywords
- Pulmonary embolism, PE
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technegas V SPECT imagingDrug
Also called Technetium-99m (Tc-99m) labeled carbon particles
Technegas V SPECT imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.
Xenon-133 Ventilation Planar imagingDrug
Also called Xe-133
Xenon-133 Ventilation Planar imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.
| Study group | Role | What they receive |
|---|---|---|
| Technegas | Experimental | Technegas V SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles; approximately 1.1 milliCuries of Technegas, compared with the results of Xenon-133 ventilation scan Receives: Drug: Technegas V SPECT imaging |
| Xenon-133 | Active comparator | Xenon-133 ventilation Planar imaging compared with the results of the Technegas scan. Receives: Drug: Xenon-133 Ventilation Planar imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Technegas V/Q SPECT for the Diagnosis of PE
Compared to the sensitivity of Xenon V/Q Planar imaging. "Truth" based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up.
Measured: Prospective, 30 days follow-up
Specificity of Technegas V/Q SPECT for the Diagnosis of PE.
Compared to the specificity of Xenon V/Q Planar imaging. "Truth" based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up.
Measured: Prospective, 30 days follow-up
Secondary outcomes (5)
Accuracy of Technegas V/Q SPECT and Xenon V/Q Planar Imaging for Diagnosis of PE
Accuracy of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.
Measured: prospective, 30 days follow-up.
Positive Predictive Value (PPV) of Imaging for Diagnosis of PE
PPV of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.
Measured: Prospective, 30 days follow-up
Negative Predictive Value (NPV) of Imaging for Diagnosis of PE
NPV of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.
Measured: Prospective, 30 days follow-up
Likelihood Ratio for Diagnosis of PE
Likelihood ratios of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.
Measured: Prospective, 30 days follow-up
Safety of Technegas in Patients With Possible PE
Safety will be assessed by the incidence of treatment emergence adverse events and changes in clinical laboratory measurements, blood pressure, oxygen saturation, physical examination and pulmonary examination before and after treatment.
Measured: Prospective, from enrollment through 30 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startAug 2012
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Decision to change trial design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary EmbolismStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyclomedica Australia PTY Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward M Aten, MD, Study director, Certus International, Inc.Akash Sharma, MD, Principal investigator, Washington University Mallinckrodt Institute of RadiologyDavid Leung, MD, PhD, Principal investigator, Columbia University Medical Center, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458639
- Sponsor's protocol ID
- CYC-008
- Status last verified
- Oct 2015
- First submitted
- 19 Oct 2011
- Last updated
- 10 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Technegas® Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging in Subjects Being Evaluated for Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT01458639
- Acronym / sponsor ID
- CYC-008
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary embolism, PE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision to change trial design.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cyclomedica Australia PTY LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Posted 10 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 3 within-subject trial of Technegas V/Q SPECT and Tc-99m macro-aggregated albumin (MAA) imaging compared to Xenon-133 V/Q planar and Tc-99m macroaggregate of albumin (MAA) imaging for the diagnosis of Pulmonary Embolism (PE).
Detailed description
This is a Phase 3 within-subject trial of Technegas Ventilation SPECT and Tc-99m MAA perfusion imaging compared to xenon (Xe-133) Ventilation Planar and Tc-99m MAA perfusion imaging for the diagnosis of PE. Diagnosis of PE provided by review of the subjects' documented clinical information after 30 days of follow-up. Primary assessments of efficacy will be based on an independent blind reads of the Technegas V/Q SPECT images by three different readers and the independent blind reads of Xe 133 V/Q planar images by three different readers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technegas | Experimental | Drug: Technegas V SPECT imagingTechnegas V SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles; approximately 1.1 milliCuries of Technegas, compared with the results of Xenon-133 ventilation scan |
| Xenon-133 | Active comparator | Drug: Xenon-133 Ventilation Planar imagingXenon-133 ventilation Planar imaging compared with the results of the Technegas scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female, at least 18 years of age.
- Suspected of having PE and be a candidate for Xe-133 V/Q imaging.
- Willing and able to provide informed consent.
- Stable and able to undergo Xe-133 planar imaging, Technegas SPECT imaging, and planar/SPECT perfusion imaging and complete follow-up procedures.
- Willing and agree to complete study procedures, including follow-up safety assessments.
Key exclusion criteria (8 listed)
- Subject
- Has undergone imaging with Iodine-131 (I-131) within 30 days, Thallium-201 (Tl-201) or Indium-111 (In-111) within 10 days, Fluorine 18 (F-18) within 24 hours, or any other radiopharmaceutical not otherwise specified within 72 hours of this imaging study.
- Has previously undergone an imaging study with a Tc-99m agent, within 48 hours of this imaging study.
- Is a pregnant or lactating female.
- Has received Technegas in the past.
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 |
|---|---|---|
| Technegas V SPECT imagingAlso: Technetium-99m (Tc-99m) labeled carbon particlesTechnegas V SPECT imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism. | Drug | Technegas |
| Xenon-133 Ventilation Planar imagingAlso: Xe-133Xenon-133 Ventilation Planar imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism. | Drug | Xenon-133 |
Primary outcome
Sensitivity of Technegas V/Q SPECT for the Diagnosis of PE
Time frame: Prospective, 30 days follow-up
Compared to the sensitivity of Xenon V/Q Planar imaging. "Truth" based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up.
Specificity of Technegas V/Q SPECT for the Diagnosis of PE.
Time frame: Prospective, 30 days follow-up
Compared to the specificity of Xenon V/Q Planar imaging. "Truth" based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up.
5 secondary outcomes
Accuracy of Technegas V/Q SPECT and Xenon V/Q Planar Imaging for Diagnosis of PE
Time frame: prospective, 30 days follow-up.
Positive Predictive Value (PPV) of Imaging for Diagnosis of PE
Time frame: Prospective, 30 days follow-up
Negative Predictive Value (NPV) of Imaging for Diagnosis of PE
Time frame: Prospective, 30 days follow-up
Likelihood Ratio for Diagnosis of PE
Time frame: Prospective, 30 days follow-up
Safety of Technegas in Patients With Possible PE
Time frame: Prospective, from enrollment through 30 days follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pulmonary Embolism
Not yet recruiting
CTEPH Differential Diagnosis Assisted by Enhanced Large Language Model Support
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)
RecruitingObservational study
Clinical Management and Outcomes After Lung Scintigraphy for Suspected Pulmonary Embolism in the Emergency Department
Pulmonary Embolism (Diagnosis)
Active, not recruitingPhase 3
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
Pulmonary Embolism
Not yet recruitingPhase 4
Reduced-Dose Versus Full-Dose Alteplase for High-Risk Pulmonary Embolism
Pulmonary Embolism Acute
Not yet recruitingPhase 2
Phase IIA Study of Belzutifan in EPAS1-, EGLN1-, or VHL-Mutant Erythrocytosis
Erythrocytosis, Pulmonary Hypertension
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.
Edward M Aten, MD study director
Certus International, Inc.
Akash Sharma, MD principal investigator
Washington University Mallinckrodt Institute of Radiology
David Leung, MD, PhD principal investigator
Columbia University Medical Center, New York, NY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Technegas V SPECT imaging and Xenon-133 Ventilation Planar imaging in people with Pulmonary Embolism, run by Cyclomedica Australia PTY Limited at 2 sites in United States.
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 14 inclusion and 8 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 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity of Technegas V/Q SPECT for the Diagnosis of PE (time frame: Prospective, 30 days follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2015.