4DX Functional Lung Imaging in the Diagnosis of Chronic Lung Allograft Dysfunction After Lung Transplantation

NCT04892719 | Completed FDA Device

• 1 other identifier: Pro00103179
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to determine the utility of Novel Functional Lung Imaging and Ventilation (4DxV) Analysis software in measurement of lung ventilation abnormalities and diagnosis of chronic lung allograft dysfunction (CLAD) after lung transplantation.

Conditions

Lung Transplant; Complications

Keywords

Lung Transplantation; Chronic Lung Allograft Dysfunction

Outcome Measures

Primary Outcomes (2)

• Ventilation defect percentage (VDP) as measured by XV lung ventilation analysis software

  Determine the VDP using XV Lung Ventilation Analysis Software to quantify ventilation in lung transplant patients

  At least one year after lung transplantation

• Regional ventilation heterogeneity percentage as measured by XV lung ventilation analysis software

  Determine the ventilation heterogeneity percentage using XV Lung Ventilation Analysis Software to quantify ventilation in lung transplant patients

  At least one year after lung transplantation

Secondary Outcomes (1)

• Calculation of Bronchiolitis Obliterans Syndrome (BOS) Stage based on FEV1 decline

  At least one year after lung transplantation

Study Arms (1)

Participants who underwent a lung transplant at Duke

OTHER

Participants will undergo fluoroscopic chest imaging with 4Dx technology software analysis

Diagnostic Test: Fluoroscopic chest imaging with 4Dx technology software analysis

Interventions

Fluoroscopic chest imaging with 4Dx technology software analysis DIAGNOSTIC_TEST

4DxV utilizes a novel software algorithm to analyze data from cinefluoroscopy images to calculate regional ventilation and pulmonary function changes. Cinefluorography uses a fluorescent screen with X-rays to make real-time moving images the lung described below. This is the same x-ray fluoroscopy that is used in clinical imaging and the fluoroscopic imaging time is approximately 1 minute leading to an effective radiation dose of 2 mSv (200 mRem). This is significantly lower that the radiation exposure from a standard chest CT. Fluoroscopy images are acquired at each of five views for approximately enough time to capture at least one complete, continuous breath. The subject is required to remain in the same position for each of the five fluoroscopy imaging sequences. These images will be analyzed by the novel 4Dx technology to provide the 4Dx lung function analysis report.

Participants who underwent a lung transplant at Duke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than or equal to 18 years of age at the time of written informed consent
• Recipient of a first bilateral lung transplantation performed at Duke University at least one year prior to written informed consent
• Computed tomography (CT) scan of the chest performed at Duke as standard of care after transplantation but within 1 year prior to written informed consent 4a. CLAD grades 1, 2,or 3 (per ISHLT 2014 criteria \[Meyer et al 2014\]) prior to or at the time of screening
• Grade 1 is defined as a fractional decrease in FEV1 to 66-80% of post-transplant baseline FEV1
• Grade 2 is defined as a fractional decrease in FEV1 to 51%-65% of post-transplant baseline FEV1
• Grade 3 is defined as a fractional decrease in FEV1 to \<= 50% of post-transplant baseline FEV14b. CLAD free status (defined as most recent FEV1 at the time of screening \>90% of post-transplant baseline FEV1)

You may not qualify if:

• Recipients of a single lung transplant
• Recipients of a redo-lung transplant
• Recipients of bone marrow or stem cell transplant
• Recipients of a multi-organ transplant
• Patients with hospital admissions(excluding admissions for planned treatment of the CLAD and/or rejection)within one month of screening.
• Patients who are unable to lie flat on the fluoroscopy table
• Pregnant women (by subject's verbal report). Lung transplant recipients are routinely counseled to avoid pregnancy due to the teratogenic effects of necessary immunosuppressant medications. Pregnancy after lung transplantation is therefore extremely rare. As this is a minimal risk study which does not involve an experimental therapy, invasive devices, or increased risk procedures, pregnancy testing is deemed unnecessary for this population for this study.

Sponsors & Collaborators

• Duke University: lead
• 4DMedical: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Meyer KC, Raghu G, Verleden GM, Corris PA, Aurora P, Wilson KC, Brozek J, Glanville AR; ISHLT/ATS/ERS BOS Task Force Committee; ISHLT/ATS/ERS BOS Task Force Committee. An international ISHLT/ATS/ERS clinical practice guideline: diagnosis and management of bronchiolitis obliterans syndrome. Eur Respir J. 2014 Dec;44(6):1479-503. doi: 10.1183/09031936.00107514. Epub 2014 Oct 30.

  PMID: 25359357 BACKGROUND

Study Officials

• Azfar Ali, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a case control design and approximately 15 lung transplant recipients will be enrolled (10 CLAD cases/5 CLAD free controls). The study procedures will be performed during a single research visit.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 19, 2021
• Study Start: October 28, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)