Clinical trial NCT01458639: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pulmonary Embolism
Keywords: Pulmonary embolism
PE
Lead sponsor: Cyclomedica Australia PTY Limited
Sponsor class: INDUSTRY
First posted: 2011-10-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Sensitivity of Technegas V/Q SPECT for the Diagnosis of PE
timeFrame: Prospective, 30 days follow-up
measure: Specificity of Technegas V/Q SPECT for the Diagnosis of PE.
timeFrame: Prospective, 30 days follow-up
Secondary outcomes:
measure: Accuracy of Technegas V/Q SPECT and Xenon V/Q Planar Imaging for Diagnosis of PE
timeFrame: prospective, 30 days follow-up.
measure: Positive Predictive Value (PPV) of Imaging for Diagnosis of PE
timeFrame: Prospective, 30 days follow-up
measure: Negative Predictive Value (NPV) of Imaging for Diagnosis of PE
timeFrame: Prospective, 30 days follow-up
measure: Likelihood Ratio for Diagnosis of PE
timeFrame: Prospective, 30 days follow-up
measure: Safety of Technegas in Patients With Possible PE
timeFrame: Prospective, from enrollment through 30 days follow-up
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Barnes-Jewish Hospital, Washington University
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Certus International, Inc.
name: Edward M Aten, MD
role: STUDY_DIRECTOR
affiliation: Washington University Mallinckrodt Institute of Radiology
name: Akash Sharma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University Medical Center, New York, NY
name: David Leung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: