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Decision to change trial design.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Xenon-133 | Active Comparator | Xenon-133 ventilation Planar imaging compared with the results of the Technegas scan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technegas V SPECT imaging | Drug | Technegas V SPECT imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Prospective, 30 days follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | prospective, 30 days follow-up. |
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Inclusion Criteria:
Subjects will be enrolled in Cohort 1 if they meet the following requirements:
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:
Exclusion Criteria:
Subject
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| Name | Affiliation | Role |
|---|---|---|
| Edward M Aten, MD | Certus International, Inc. | Study Director |
| Akash Sharma, MD | Washington University Mallinckrodt Institute of Radiology | Principal Investigator |
| David Leung, MD, PhD | Columbia University Medical Center, New York, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes-Jewish Hospital, Washington University | St Louis | Missouri | 63110 | United States | ||
| Columbia University Medical Center |
Subjects suspected of PE to have Xe-133 ventilation/Tc-99m macroaggregated albumin (MAA) perfusion (VQ) scan. Must have at least one within 72 hours before imaging: D-dimer, Doppler ultrasound for deep vein thrombosis (DVT) or computed tomography angiography (CTA) for PE. Not have therapeutic dose blood thinner for > than 72 hrs prior to imaging.
The recruitment period was November 14, 2012 to June 11, 2014. Subjects were recruited from US medical centers that performed Xenon-133 ventilation scans to evaluate patients for pulmonary embolism (PE).
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Xenon-133 Ventilation Planar imaging | Drug | Xenon-133 Ventilation Planar imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism. |
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| 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. | 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. | 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. | 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. | Prospective, from enrollment through 30 days follow-up |
| New York |
| New York |
| 10032 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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All subjects enrolled in the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Pulmonary embolism adjudication was to be determined by an Independent Adjudication Committee for primary and secondary outcome data and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done. | Posted | Prospective, 30 days follow-up |
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| |||||||||||||||||||
| Primary | 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. | Pulmonary embolism adjudication was to be determined by an Independent Adjudication Committee for primary and secondary outcome data and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done. | Posted | Prospective, 30 days follow-up |
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| Secondary | 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. | PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done. | Posted | prospective, 30 days follow-up. |
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| Secondary | 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. | PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done. | Posted | Prospective, 30 days follow-up |
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| Secondary | 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. | PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done. | Posted | Prospective, 30 days follow-up |
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| Secondary | 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. | PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done. | Posted | Prospective, 30 days follow-up |
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| Secondary | 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. | All subjects who received Technegas and completed safety follow-up procedures. | Posted | Number | participants | Prospective, from enrollment through 30 days follow-up |
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24 (+/- 4) hours post Technegas ventilation/perfusion (V/Q) scan.
Safety assessment was performed from the start of the Xe-133 ventilation scan, followed by the Technegas ventilation scan, followed by the Tc-99m MAA scan until 24 (+/- 4) hours after the Technegas ventilation scan.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Study | Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results. | 0 | 12 | 1 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Systolic blood pressure increase | Investigations | MedDRA 15.0 | Systematic Assessment | 24 min. post Technegas administration, subject had increase in systolic blood pressure (SBP) from 103 to 140 mmHg (increase of 37) meeting protocol definition SBP increase > 35 mmHg being clinically significant. Resolved spontaneously in 2 min. |
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PE adjudication by Independent Committee for final clinical diagnosis and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were not performed due to early trial termination. No efficacy data available.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Somerville, Quality and Regulatory Manager | Cyclomedica Australia Pty Ltd | +61 (0)2 9541 0411 | gsomerville@cyclomedica.com.au |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013667 | Technetium |
| C000614978 | Xenon-133 |
| ID | Term |
|---|---|
| D004603 | Elements, Radioactive |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019216 | Metals, Heavy |
| D028561 | Transition Elements |
| D011868 | Radioisotopes |
| D007554 | Isotopes |
| D008670 | Metals |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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