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

Primary Purpose

Pulmonary Embolism

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Technegas V SPECT imaging
Xenon-133 Ventilation Planar imaging
Sponsored by
Cyclomedica Australia PTY Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Embolism focused on measuring Pulmonary embolism, PE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barnes-Jewish Hospital, Washington University
  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Technegas

Xenon-133

Arm Description

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

Xenon-133 ventilation Planar imaging compared with the results of the Technegas scan.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
October 19, 2011
Last Updated
October 13, 2015
Sponsor
Cyclomedica Australia PTY Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01458639
Brief Title
Compare Technegas Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging for Pulmonary Embolism
Official Title
A Comparison of Technegas® Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging in Subjects Being Evaluated for Pulmonary Embolism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Decision to change trial design.
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cyclomedica Australia PTY Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
Pulmonary embolism, PE

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Technegas
Arm Type
Experimental
Arm Description
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
Arm Title
Xenon-133
Arm Type
Active Comparator
Arm Description
Xenon-133 ventilation Planar imaging compared with the results of the Technegas scan.
Intervention Type
Drug
Intervention Name(s)
Technegas V SPECT imaging
Other Intervention Name(s)
Technetium-99m (Tc-99m) labeled carbon particles
Intervention Description
Technegas V SPECT imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.
Intervention Type
Drug
Intervention Name(s)
Xenon-133 Ventilation Planar imaging
Other Intervention Name(s)
Xe-133
Intervention Description
Xenon-133 Ventilation Planar imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.
Primary Outcome Measure Information:
Title
Sensitivity of Technegas V/Q SPECT for the Diagnosis of PE
Description
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
Title
Specificity of Technegas V/Q SPECT for the Diagnosis of PE.
Description
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
Secondary Outcome Measure Information:
Title
Accuracy of Technegas V/Q SPECT and Xenon V/Q Planar Imaging for Diagnosis of PE
Description
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.
Title
Positive Predictive Value (PPV) of Imaging for Diagnosis of PE
Description
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
Title
Negative Predictive Value (NPV) of Imaging for Diagnosis of PE
Description
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
Title
Likelihood Ratio for Diagnosis of PE
Description
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
Title
Safety of Technegas in Patients With Possible PE
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward M Aten, MD
Organizational Affiliation
Certus International, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Akash Sharma, MD
Organizational Affiliation
Washington University Mallinckrodt Institute of Radiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Leung, MD, PhD
Organizational Affiliation
Columbia University Medical Center, New York, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-Jewish Hospital, Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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