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A Comparison of Technegas and Xenon-133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy

NCT03054870 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2021-09-24

Study results available
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Summary

Phase 3 within-subject non-inferiority trial of Technegas ventilation imaging compared to Xenon-133 (Xe-133) ventilation imaging to demonstrate the non-inferiority of Technegas compared to Xe-133 ventilation studies with respect to subject pulmonary ventilatory distribution. Subjects will undergo site-specific standard of care (SOC) Xe-133 imaging per medical needs followed by Technegas ventilation imaging per study protocol.

Conditions

  • Lung Structure Determination

Interventions

DRUG

Xe-133

Xe-133 ventilation scintigraphy

DRUG

Technegas

Technegas ventilation scintigraphy

Sponsors & Collaborators

  • Cyclomedica Australia PTY Limited

    lead INDUSTRY

Principal Investigators

  • Edward M Aten, MD · Certus International, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2020-09-18
Completion
2020-11-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03054870 on ClinicalTrials.gov