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

NCT ID: NCT01458639

Last Updated: 2015-11-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-06-30

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.

Conditions

Pulmonary Embolism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Technegas V SPECT imaging

Intervention Type: DRUG

Technegas V SPECT imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.

Xenon-133

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

Group Type: ACTIVE_COMPARATOR

Xenon-133 Ventilation Planar imaging

Intervention Type: DRUG

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

Interventions

Technegas V SPECT imaging

Technegas V SPECT imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.

Intervention Type: DRUG

Xenon-133 Ventilation Planar imaging

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

Intervention Type: DRUG

Other Intervention Names

Technetium-99m (Tc-99m) labeled carbon particles; Xe-133

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cyclomedica Australia PTY Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward M Aten, MD

Role: STUDY_DIRECTOR

Certus International, Inc.

Akash Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University Mallinckrodt Institute of Radiology

David Leung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University Medical Center, New York, NY

Locations

Barnes-Jewish Hospital, Washington University

St Louis, Missouri, United States

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

CYC-008

Identifier Type: -

Identifier Source: org_study_id