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

Cyclomedica

Status and phase: Terminated; Phase 3

Conditions: Lung Structure Determination

Treatments: Drug: Xe-133; Drug: Technegas

Study type: Interventional

Funder types: Industry

Identifiers

NCT03054870

CYC-009

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 226 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Crossover Assignment

Masking: None (Open label)

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226 participants in 1 patient group

Xe-133 Followed by Technegas

Other group

Description:

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.

Treatment:

Drug: Technegas

Drug: Xe-133