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Apoptosis Imaging for COPD

Phase 2

Waitlist Available

Led By Gebhard Wagener, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with severe COPD: GOLD Stage III-IV, FEV1/FVC < 0.7 and FEV1 < 50% predicted

Patients with moderate COPD: Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage II, forced expiratory volume 1 (FEV1)/forced vital capacity (FVC) < 0.7 and FEV1 50-79% predicted

Must not have

Age < 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months from the initial scan

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how COPD affects the lung using imaging and functional tests. It will compare COPD patients, smokers and non-smokers.

Who is the study for?

This trial is for adults with severe to moderate COPD, as well as healthy adult smokers and non-smokers. Participants must meet specific breathing test criteria (like FEV1/FVC ratios) that show how well their lungs work.

What is being tested?

The study is testing a special type of lung scan called SPECT-CT imaging using AxV-128/Tc. It aims to see if this method can better detect changes in the lungs of people with COPD compared to those without it.

What are the potential side effects?

Since this trial involves imaging techniques, side effects may include discomfort from staying still during scans and exposure to radiation typical for CT scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe COPD with significant breathing test abnormalities.

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I have moderate COPD as per GOLD Stage II.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months from the initial scan

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months from the initial scan

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months from the initial scan for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean AxV-128/Tc Uptake

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Patients with severe COPDExperimental Treatment2 Interventions

Patients with severe COPD will be injected with AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).

Group II: Patients with moderate COPDExperimental Treatment2 Interventions

Patients with moderate COPD will be injected with AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).

Group III: Healthy volunteersExperimental Treatment2 Interventions

Healthy controls who never smoked (less than 100 lifetime cigarettes) with normal spirometry will be injected with AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).

Group IV: Current smokersExperimental Treatment2 Interventions

Healthy controls who are currently smoking (\> 10 pack years) with normal spirometry will be injected with AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).

0 / 3Eligibility criteria met