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

C

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

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

Trial documents
3

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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