A Phase 3 interventional study of Technegas V SPECT imaging and Xenon-133 Ventilation Planar imaging in Pulmonary Embolism, sponsored by Cyclomedica Australia PTY Limited. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-10.
Sponsored by Cyclomedica Australia PTY Limited · Phase 3, Interventional, and Diagnostic
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.
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's enrollment of 18 is below the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Cyclomedica Australia PTY Limited is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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
Drug: Technegas V SPECT imaging
Xenon-133 ventilation Planar imaging compared with the results of the Technegas scan.
Drug: Xenon-133 Ventilation Planar imaging
Technegas V SPECT imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.
Also known as: Technetium-99m (Tc-99m) labeled carbon particles
Xenon-133 Ventilation Planar imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.
Also known as: Xe-133
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.
Time frame: 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.
Time frame: Prospective, 30 days follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Prospective, from enrollment through 30 days follow-up
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).
| Milestone | Overall Study |
|---|---|
| Started | 18 |
| Completed | 12 |
| Not completed | 6 |
| Withdrew: Physician decision | 4 |
| Withdrew: Equipment issue | 1 |
| Withdrew: Inability to obtain subject blood sample | 1 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
| participants | Overall Study |
|---|---|
| Serious adverse events | 0 |
| Other (not including serious) adverse events | 1 |
Collected over 24 (+/- 4) hours post Technegas ventilation/perfusion (V/Q) scan.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall Study | — | 0/12 (0%) | 1/12 (8.3%) |
| Event | Overall Study |
|---|---|
| Systolic blood pressure increaseInvestigations | 1/12 |
All subjects enrolled in the trial.
| Age, Categorical(Participants) | Overall Study |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 6 |
| Age, Continuous(years) | Overall Study |
|---|---|
| Mean | 59.5 (34 to 81) |
| Sex: Female, Male(Participants) | Overall Study |
|---|---|
| Female | 7 |
| Male | 11 |
| Ethnicity (NIH/OMB)(Participants) | Overall Study |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Overall Study |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 8 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Overall Study |
|---|---|
| United States | 18 |
This study is terminated, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Cyclomedica Australia PTY Limited