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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-11-23

Brief Summary

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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.

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Detailed Description

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This is a 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. Primary assessments of efficacy will be based on three blinded readers' assessments of the Technegas and Xe-133 ventilation images in independent reading sessions.

Conditions

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Lung Structure Determination

Study Design

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Allocation Method

NA

Intervention Model

CROSSOVER

Subjects will undergo standard of care Xe-133 ventilation scintigraphy per medical needs followed by investigational Technegas ventilation scintigraphy per protocol.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Independent blinded readers will assess all ventilation scintigraphy images, masked as to subject identity and re-identified with a unique random code number (different code numbers for Xe-133 and Technegas images). The Xe-133 and Technegas images will be read in separate reading sessions in random order.

Study Groups

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Xe-133 Followed by Technegas

Subjects first inhaled active comparator Xe-133, approximately 10 to 30 millicuries (mCi), and ventilation planar scintigraphy was performed per site standard of care procedures for subject medical need. On the same day, following completion of Xe-133 imaging, subjects inhaled experimental Technegas (Technetium-99m labeled carbon particles), approximately 1.1 mCi, and ventilation planar scintigraphy was performed.

Group Type OTHER

Xe-133

Intervention Type DRUG

Xe-133 ventilation scintigraphy

Technegas

Intervention Type DRUG

Technegas ventilation scintigraphy

Interventions

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Xe-133

Xe-133 ventilation scintigraphy

Intervention Type DRUG

Technegas

Technegas ventilation scintigraphy

Intervention Type DRUG

Other Intervention Names

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Xenon-133 Xenon gas Technetium-99m labeled carbon particles

Eligibility Criteria

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Inclusion Criteria

* Male or female subject at least 18 years of age.
* Subject is a candidate for ventilation imaging.
* Subject must be willing and able to provide informed consent.
* Subject must be stable and able to undergo Xe-133 planar imaging and Technegas planar imaging.
* Subject must be willing and agree to complete study procedures.
* Subject is using adequate birth control, if female and fertile. Adequate birth control is defined as surgical sterilization, hormone contraceptive use or intrauterine device (IUD).
* Female subject of child-bearing potential has a negative urine or serum pregnancy test.
* Subject has had or is scheduled to have a chest X-ray within 24 hours prior to the investigational imaging study.

Exclusion Criteria

* Subject has been administered any other radiopharmaceutical within a timeframe that might cause interference with study imaging.
* Subject is a pregnant or lactating female.
* Subject has received Technegas in the past.
* Subject has received an investigational drug within 30 days prior to dosing.
* Subject is hemodynamically unstable.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No