Lung Structure DeterminationPhase 3NCT03054870

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

A Phase 3 study testing Xe-133 and Technegas in people with Lung Structure Determination, run by Cyclomedica Australia PTY Limited at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Structure Determination
What is being tested?: Xe-133 and Technegas
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 226 participants
Where: 9 sitesUnited States
Study dates: 1 Sep 2017to 23 Nov 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Morton Plant Hospital
Clearwater, Florida, 33756
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University Hospital
Durham, North Carolina, 27710
Houston Methodist Hospital
Houston, Texas, 77030
Mayo Clinic in Jacksonville, FL
Jacksonville, Florida, 32224
Loyola University Medical Center
Maywood, Illinois, 60153
University of Utah Health Science Center
Salt Lake City, Utah, 84132
Washington University Medical Center, Barnes-Jewish Hospital - Center for Advanced Medicine
St Louis, Missouri, 63110
Scott & White Medical Center
Temple, Texas, 76508

Other trials in United States

About this study

Official title: A Comparison of Technegas® and Xenon 133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy

Read the detailed 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.

Conditions: Lung Structure Determination
Being tested: Xe-133, Technegas
Keywords: pulmonary ventilation, ventilation scintigraphy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Xe-133Drug
Also called Xenon-133, Xenon gas
Xe-133 ventilation scintigraphy
TechnegasDrug
Also called Technetium-99m labeled carbon particles
Technegas ventilation scintigraphy

Study groups in NCT03054870
Study group	Role	What they receive
Xe-133 Followed by Technegas	Other	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. Receives: Drug: Xe-133; Drug: Technegas

What is being measured

The primary outcome is the main question the study is designed to answer.

Blinded Readers Percent Agreement (PA) for Matching Image Views
Three blinded readers independently assessed the Xe-133 and Technegas images in separate reading sessions. Readers were blinded to all clinical information except a subject's screening chest X-ray. Xe-133 images were obtained per site-specific standard of care. Technegas images included a 6-view image set, and the primary endpoint was based on assessment of the subset of views that matched the Xe-133 image views. At the start of each case-read, a reader visually divided each lung into 3 regions of approximately equal size arranged craniocaudally (apical, mid, and basal), 6 regions in total, and then assessed each lung region for ventilation according to a three-point scale: 0=absent ventilation, 1=decreased ventilation, 2=normal ventilation. At the unplanned interim stage, PA between the Xe-133 scores and Technegas scores was tested for non-inferiority at one-sided alpha=0.0141, equivalent to the lower bound of the 97.18% confidence interval exceeding 60%.
Measured: The median duration of Technegas imaging was 22 minutes. Blinded reader assessments of images ranged from <1 month to 16 months following the imaging (median 5 months).

Secondary outcomes (3)

Blinded Readers Percent Agreement (PA) for All Image Views
Three blinded readers independently assessed the Xe-133 and Technegas images in separate reading sessions. Readers were blinded to all clinical information except a subject's screening chest X-ray. Xe-133 images were obtained per site-specific standard of care. Technegas images included a 6-view image set. Two sequential reads were conducted of each subject's Technegas images. In the first read, only views that matched the Xe-133 image views were presented and read, and assessments based on the matched views were used in the primary outcome measure. Immediately following the commitment of those assessments, all Technegas image views were presented to the reader, and a second assessment of all the Technegas image views was made using the same ventilation scoring metric as described for the primary outcome measure. The estimation of PA and its analyses were also the same as for the primary outcome measure.
Measured: The median duration of Technegas imaging was 22 minutes. Blinded reader assessments of images ranged from <1 month to 16 months following the imaging (median 5 months).
Percent Agreement Measuring Inter-observer Agreement
Percent agreement (PA) measuring inter-observer agreement between pairs of blinded readers for their ventilation scoring assessments within each of the three imaging groups: Xe-133, Technegas matched views, and Technegas all views. For each image set, a reader scored 6 regions of the lungs according to a three-point scale: 0=absent ventilation, 1=decreased ventilation, 2=normal ventilation; agreement between a pair of readers' assessments was based on the agreement of their ventilation scores by subject and lung region.
Measured: The median duration of Technegas imaging was 22 minutes. Blinded reader assessments of images ranged from <1 month to 16 months following the imaging (median 5 months).
Kappa Statistics Between Pairs of Blinded Readers by Lung Region
By lung-region kappa statistics measuring inter-observer agreement between pairs of blinded readers for their ventilation scoring assessments within each of the three imaging groups: Xe-133, Technegas matched views, and Technegas all views. For each image set, a reader scored 6 regions of the lungs according to a three-point scale: 0=absent ventilation, 1=decreased ventilation, 2=normal ventilation. Kappa statistics for a pair of readers' assessments were derived from the frequencies of the cross-tabulation of the readers' ventilation scores by lung region. Kappa statistics are an index of inter-observer agreement corrected for chance with possible values ranging from -1 to 1, where 1 represents perfect agreement.
Measured: The median duration of Technegas imaging was 22 minutes. Blinded reader assessments of images ranged from <1 month to 16 months following the imaging (median 5 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201723 Nov 2020

First posted16 Feb 2017
Study start1 Sep 2017
Primary completion18 Sep 2020
Study completion23 Nov 2020

Why it stopped: Trial met primary efficacy endpoint target. No additional subjects necessary.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lung Structure DeterminationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Other
Allocation: Not applicable
Intervention model: Crossover
Model description: Subjects will undergo standard of care Xe-133 ventilation scintigraphy per medical needs followed by investigational Technegas ventilation scintigraphy per protocol.
Masking: None (open label)
Enrolment: 226 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03054870
Sponsor's protocol ID: CYC-009
Status last verified: Aug 2021
First submitted: 8 Feb 2017
Last updated: 24 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Parihar AS, Mhlanga JC, Royal HD, Siegel BA. Comparability of Quantifying Relative Lung Ventilation with Inhaled 99mTc-Technegas and 133Xe in Patients Undergoing Evaluation for Lung Transplantation. J Nucl Med. 2025 Jan 3;66(1):104-109. doi: 10.2967/jnumed.124.268801.
PubMed 39638430

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Technegas® and Xenon 133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy
ClinicalTrials.gov ID: NCT03054870
Acronym / sponsor ID: CYC-009
Conditions: Lung Structure Determination
Keywords: pulmonary ventilation, ventilation scintigraphy
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Trial met primary efficacy endpoint target. No additional subjects necessary.
Enrolment: 226 participants (actual)
Lead sponsor: Cyclomedica Australia PTY LimitedIndustry (pharma, biotech, devices)
Study start: 1 Sep 2017 (actual)
Primary completion: 18 Sep 2020 (actual)
Study completion: 23 Nov 2020 (actual)
First posted: 16 Feb 2017 (actual)
Results: Posted 24 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Crossover
Masking: None (open label)
Number of arms: 1
Model description: Subjects will undergo standard of care Xe-133 ventilation scintigraphy per medical needs followed by investigational Technegas ventilation scintigraphy per protocol.

Arm	Type	Receives
Xe-133 Followed by Technegas	Other	Drug: Xe-133, Drug: TechnegasSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Xe-133Also: Xenon-133, Xenon gasXe-133 ventilation scintigraphy	Drug	Xe-133 Followed by Technegas
TechnegasAlso: Technetium-99m labeled carbon particlesTechnegas ventilation scintigraphy	Drug	Xe-133 Followed by Technegas

Primary outcome

Blinded Readers Percent Agreement (PA) for Matching Image Views
Time frame: The median duration of Technegas imaging was 22 minutes. Blinded reader assessments of images ranged from <1 month to 16 months following the imaging (median 5 months).
Three blinded readers independently assessed the Xe-133 and Technegas images in separate reading sessions. Readers were blinded to all clinical information except a subject's screening chest X-ray. Xe-133 images were obtained per site-specific standard of care. Technegas images included a 6-view image set, and the primary endpoint was based on assessment of the subset of views that matched the Xe-133 image views. At the start of each case-read, a reader visually divided each lung into 3 regions of approximately equal size arranged craniocaudally (apical, mid, and basal), 6 regions in total, and then assessed each lung region for ventilation according to a three-point scale: 0=absent ventilation, 1=decreased ventilation, 2=normal ventilation. At the unplanned interim stage, PA between the Xe-133 scores and Technegas scores was tested for non-inferiority at one-sided alpha=0.0141, equivalent to the lower bound of the 97.18% confidence interval exceeding 60%.

3 secondary outcomes

Blinded Readers Percent Agreement (PA) for All Image Views
Time frame: The median duration of Technegas imaging was 22 minutes. Blinded reader assessments of images ranged from <1 month to 16 months following the imaging (median 5 months).
Percent Agreement Measuring Inter-observer Agreement
Time frame: The median duration of Technegas imaging was 22 minutes. Blinded reader assessments of images ranged from <1 month to 16 months following the imaging (median 5 months).
Kappa Statistics Between Pairs of Blinded Readers by Lung Region
Time frame: The median duration of Technegas imaging was 22 minutes. Blinded reader assessments of images ranged from <1 month to 16 months following the imaging (median 5 months).

Results and safety

Results posted to the registry on 24 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Xe-133 Followed by Technegas	210	205

Primary outcome: Blinded Readers Percent Agreement (PA) for Matching Image Views

Time frame: The median duration of Technegas imaging was 22 minutes. Blinded reader assessments of images ranged from <1 month to 16 months following the imaging (median 5 months).. Number (97.18% Confidence Interval). Unit: percentage of lung regions

Measure	Blinded Reader 03 n = 200	Blinded Reader 04 n = 200	Blinded Reader 05 n = 200
Value	76.2 (72.3 to 79.6)	70.7 (66.4 to 74.7)	80.1 (76.4 to 83.3)

Blinded Reader 03 vs Blinded Reader 04 vs Blinded Reader 05: p <0.0141, Mixed Models Analysis

Population analysed: Full Analysis Set (FAS) consisting of subjects who completed all of the ventilation imaging on the study, and both sets of Xe-133 planar scans and the Technegas planar scans were of interpretable image quality according to site Investigators' assessment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of Informed Consent until study discharge. Under the original protocol discharge followed 24-hour follow-up. Under the amended protocol, 24-hour follow-up was removed and discharge followed study imaging.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Xe-133 Followed by Technegas	0 of 210 (0%)	7 of 210 (3.3%)	0 of 210

Limitations and caveats (from the sponsor): Unblinded analysis of imaging efficacy data was to be done at completion of study and all blinded readings. Due to the COVID-19 pandemic impact on enrollment, FDA recommended an unplanned interim analysis be performed using blind read data from 200 subjects. Interim analysis was done by independent 3rd party statistician and reviewed by a Data Efficacy Monitoring Committee (DEMC), which recommended termination of the study based on positive results. Sponsor agreed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39638430Parihar AS, Mhlanga JC, Royal HD, Siegel BA. Comparability of Quantifying Relative Lung Ventilation with Inhaled 99mTc-Technegas and 133Xe in Patients Undergoing Evaluation for Lung Transplantation. J Nucl Med. 2025 Jan 3;66(1):104-109. doi: 10.2967/jnumed.124.268801.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Edward M Aten, MD study director

Certus International, Inc.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Xe-133 and Technegas in people with Lung Structure Determination, run by Cyclomedica Australia PTY Limited at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blinded Readers Percent Agreement (PA) for Matching Image Views (time frame: The median duration of Technegas imaging was 22 minutes. Blinded reader assessments of images ranged from <1 month to 16 months following the imaging (median 5 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03054870, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.