Apoptosis Imaging for COPD

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byGebhard Wagener, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Columbia University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This will be a prospective study examining the use of 99mTc-Annexin V-128 (AxV-128/Tc) single-photon emission computed tomography (SPECT)/computerized tomography (CT) technology in the imaging and functional assessment of the lung of patients with chronic obstructive pulmonary disease (COPD), healthy volunteer smokers without COPD and healthy volunteer subjects without smoking history. The aim of study is to determine if patients with COPD have an increased AxV-128/Tc signal with SPECT/CT.

Eligibility Criteria

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.

Inclusion Criteria

I have severe COPD with significant breathing test abnormalities.

People who have never smoked a lot and have normal lung function test results.

I have moderate COPD as per GOLD Stage II.

+1 more

Exclusion Criteria

I am under 18 years old.

Participant Groups

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.

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).