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

NCT01458639 | Terminated Phase 3 Results DMC

• 1 other identifier: CYC-008
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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).

Conditions

Pulmonary Embolism

Keywords

Pulmonary embolism; PE

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Accuracy of Technegas V/Q SPECT and Xenon V/Q Planar Imaging for Diagnosis of PE

  prospective, 30 days follow-up.

• Positive Predictive Value (PPV) of Imaging for Diagnosis of PE

  Prospective, 30 days follow-up

• Negative Predictive Value (NPV) of Imaging for Diagnosis of PE

  Prospective, 30 days follow-up

• Likelihood Ratio for Diagnosis of PE

  Prospective, 30 days follow-up

• Safety of Technegas in Patients With Possible PE

  Prospective, from enrollment through 30 days follow-up

Study Arms (2)

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

Drug: Technegas V SPECT imaging

Xenon-133

ACTIVE COMPARATOR

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

Drug: Xenon-133 Ventilation Planar imaging

Interventions

Technegas V SPECT imaging DRUG

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

Technegas

Xenon-133 Ventilation Planar imaging DRUG

Xenon-133 Ventilation Planar imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.

Also known as: Xe-133

Xenon-133

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cyclomedica Australia PTY Limited: lead

Study Sites (2)

Barnes-Jewish Hospital, Washington University

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Technetium; Xenon-133

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Transition Elements; Radioisotopes; Isotopes; Metals

Limitations and Caveats

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.

Results Point of Contact

• Title: Gary Somerville, Quality and Regulatory Manager
• Organization: Cyclomedica Australia Pty Ltd

gsomerville@cyclomedica.com.au

+61 (0)2 9541 0411

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: October 25, 2011
• Study Start: August 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 10, 2015
• Results First Posted: November 10, 2015

Record last verified: 2015-10

Locations

US (2)