Compare Technegas Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging for Pulmonary Embolism

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).

Study Overview

• Status: Terminated
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Drug: Technegas V SPECT imaging; Drug: Xenon-133 Ventilation Planar imaging

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital, Washington University
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects will be enrolled in Cohort 1 if they meet the following requirements:

1. Male or female, at least 18 years of age.
2. Suspected of having PE and be a candidate for Xe-133 V/Q imaging.
3. Willing and able to provide informed consent.
4. Stable and able to undergo Xe-133 planar imaging, Technegas SPECT imaging, and planar/SPECT perfusion imaging and complete follow-up procedures.
5. Willing and agree to complete study procedures, including follow-up safety assessments.
6. Using adequate birth control, if female and fertile.
7. If female, has a negative urine or serum pregnancy test.
8. 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:

1. 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.
2. An abnormal D-dimer test.
3. Positive Doppler ultrasound for DVT.
4. CTA is positive for PE within 24 hours of this imaging study.

Exclusion Criteria:

Subject

1. 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.
2. Has previously undergone an imaging study with a Tc-99m agent, within 48 hours of this imaging study.
3. Is a pregnant or lactating female.
4. Has received Technegas in the past.
5. Was previously enrolled in another investigational study or received an investigational drug within 30 days prior to dosing.
6. Is hemodynamically unstable.
7. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Technegas; 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; Technegas V SPECT imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.; Other Names: Technetium-99m (Tc-99m) labeled carbon particles
Active Comparator: Xenon-133; Xenon-133 ventilation Planar imaging compared with the results of the Technegas scan.	Drug: Xenon-133 Ventilation Planar imaging; Xenon-133 Ventilation Planar imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.; Other Names: Xe-133

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.
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

Collaborators and Investigators

• Sponsor: Cyclomedica Australia PTY Limited
• Investigators: Study Director: Edward M Aten, MD, Certus International, Inc.; Principal Investigator: Akash Sharma, MD, Washington University Mallinckrodt Institute of Radiology; Principal Investigator: David Leung, MD, PhD, Columbia University Medical Center, New York, NY

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: October 24, 2011
• First Posted (Estimate): October 25, 2011

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Pulmonary embolism; PE
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Xenon
• Other Study ID Numbers: CYC-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No