Clinical Utility of Portable Dynamic Chest X Ray (DDR) in the ICU

NCT06538376 | Recruiting FDA Device

• 1 other identifier: 2023P001100
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

Dynamic digital radiography (DDR) is a new advanced version of chest radiography that captures dynamic images at a rate of 15 frames per second. It is coupled with an analytical software that allows it to provide more advanced measures of lung motion, ventilation, and perfusion compared to traditional chest radiography. While implementation of DDR fixed machines are beginning elsewhere in the US, this trial involves the first applications of an FDA-approved portable DDR machine, for use at the bedside in the ICU. The goal of this clinical trial is to determine the feasibility and safety of portable DDR technology in the ICU, as well as to evaluate the improved clinical diagnostic value of the portable DDR system over current standards of care. Participants will receive one to three sets of DDR images, which will then be compared to their clinical gold standard exams (such as chest x-rays, CTs, or VQ scans) to assess and improve the precision and accuracy of measurements such as diaphragmatic motion, lung movement, and perfusion.

Conditions

Pulmonary Edema; Pneumonia; Atelectasis; Pleural Effusion; Acute Rejection of Lung Transplant (Disorder); Airway Obstruction; Rib Fractures; Acute Copd Exacerbation; Asthma COPD; Pulmonary Embolism; Hemothorax; Pneumothorax; Mesothelioma; Diaphragmatic Paralysis

Outcome Measures

Primary Outcomes (2)

• I. Extended clinical trial to study the degree of precision of the Portable DDR technology in assessing the cardiopulmonary functions of diaphragm and lung motion.

  Hypothesis: The Portable DDR technology can improve the visualization of parameters associated with lung physiology for ICU patients (diaphragmatic motion, lung motion) compared to current standards of care for imaging. Aim I-1: Determine the diagnostic precision of Portable DDR technology vs. routine standard of care imaging for specific lung pathologies (for example in pre- and post-transplant patients) that affect the mentioned cardiopulmonary functions. The DDR's precision will be measured by using the most relevant diagnostic procedure, the gold standard, for the condition will be used as reference to assess both qualitative and semiquantitative or quantitative information yielded by both types of imaging. The golden standard images for each of these parameters are: 1\. Diaphragmatic/Lung motion: Ultrasound imaging.

  Up to 2 months

• II. Extended clinical trial to study the degree of precision of the Portable DDR technology in assessing the cardiopulmonary functions of pulmonary blood flow.

  Hypothesis: The Portable DDR technology can improve the visualization of parameters associated with lung physiology for ICU patients (pulmonary blood flow) compared to current standards of care for imaging. Aim II-1: Determine the diagnostic precision of Portable DDR technology vs. routine standard of care imaging for specific lung pathologies (for example in pre- and post-transplant patients) that affect the mentioned cardiopulmonary function. The DDR's precision will be measured by using the most relevant diagnostic procedure, the gold standard, for the condition will be used as reference to assess both qualitative and semiquantitative or quantitative information yielded by both types of imaging. The golden standard image for this parameter is: 1\. Pulmonary blood flow: VQ scan or pulmonary angiograms The comparisons in precision for both diaphragm/lung motion and pulmonary blood flow will be aggregated to determine overall precision of the DDR technology

  Up to 2 months

Study Arms (1)

Portable Dynamic Digital Radiography (DDR) + Clinical Gold Standard Imaging

EXPERIMENTAL

Dynamic digital radiography (DDR) is a new version of chest radiography from Konica Minolta (KM) that provides more advanced measures of lung motion, ventilation, and perfusion compared to traditional chest radiography. DDR scans are dynamic images that have a rate of 15 frames per second (for 7-20 seconds), acting as a mini-fluorography machine with radiation that is only slightly greater than a traditional chest x-ray. Every patient will receive both a DDR scan and a gold standard scan. Each patient's DDR images will be compared to the golden standard that is completed as part of the patient's routine standard of care. For instance, for many ICU patients this includes traditional chest x-rays, ultrasounds or VQ scans.

Diagnostic Test: Portable Dynamic Digital Radiography (DDR)

Interventions

Portable Dynamic Digital Radiography (DDR) DIAGNOSTIC_TEST

(DDR imaging has already been described in the arm/group description). Each patient in the study will receive at least one set of DDR images, which consists of one 7-second scan in which the patient breaths normally, and a second 7-second scan in which the patient holds their breath (or for ventilated patients, an inspiratory pause is placed by the care team). If the patient's conditions warrant it, up to two sets of follow-up scans may be acquired. For instance, in a patient with diaphragmatic dysfunction, imaging may be completed pre- and post- diaphragmatic plication.

Portable Dynamic Digital Radiography (DDR) + Clinical Gold Standard Imaging

Eligibility Criteria

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

You may qualify if:

• Adults (at least 18 years of age) including both intubated/ventilated and non-intubated patients
• Likely to have pathology related to either, abnormal diaphragmatic excursion and lung aeration, pulmonary perfusion, increased lung water content or all the above, as well as for cricopharyngeal dysfunction/swallowing difficulties at risk for aspiration.
• The subject or a legally authorized representative has provided written informed consent.

You may not qualify if:

• Special populations, including women with known pregnancy, prisoners, or institutionalized individuals
• Patients where additional radiation is clinically contraindicated
• Care team does not provide assent for approaching patient/surrogate
• For women of child-bearing potential, defined as premenopausal women, a pregnancy test will be administered to determine pregnancy status and confirm eligibility for the study. A pregnancy test will NOT be administered to women who are post-menopausal or have documentation of surgical sterilization.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Konica Minolta: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (7)

• Hata A, Yamada Y, Tanaka R, Nishino M, Hida T, Hino T, Ueyama M, Yanagawa M, Kamitani T, Kurosaki A, Sanada S, Jinzaki M, Ishigami K, Tomiyama N, Honda H, Kudoh S, Hatabu H. Dynamic Chest X-Ray Using a Flat-Panel Detector System: Technique and Applications. Korean J Radiol. 2021 Apr;22(4):634-651. doi: 10.3348/kjr.2020.1136. Epub 2020 Nov 30.

  PMID: 33289365 BACKGROUND

• Fyles F, FitzMaurice TS, Robinson RE, Bedi R, Burhan H, Walshaw MJ. Dynamic chest radiography: a state-of-the-art review. Insights Imaging. 2023 Jun 19;14(1):107. doi: 10.1186/s13244-023-01451-4.

  PMID: 37332064 BACKGROUND

• Ce M, Oliva G, Rabaiotti FL, Macri L, Zollo S, Aquila A, Cellina M. Portable Dynamic Chest Radiography: Literature Review and Potential Bedside Applications. Med Sci (Basel). 2024 Feb 7;12(1):10. doi: 10.3390/medsci12010010.

  PMID: 38390860 BACKGROUND

• Yamada Y, Ueyama M, Abe T, Araki T, Abe T, Nishino M, Jinzaki M, Hatabu H, Kudoh S. Time-Resolved Quantitative Analysis of the Diaphragms During Tidal Breathing in a Standing Position Using Dynamic Chest Radiography with a Flat Panel Detector System ("Dynamic X-Ray Phrenicography"): Initial Experience in 172 Volunteers. Acad Radiol. 2017 Apr;24(4):393-400. doi: 10.1016/j.acra.2016.11.014. Epub 2016 Dec 15.

  PMID: 27989446 BACKGROUND

• Hida T, Yamada Y, Ueyama M, Araki T, Nishino M, Kurosaki A, Jinzaki M, Honda H, Hatabu H, Kudoh S. Time-resolved quantitative evaluation of diaphragmatic motion during forced breathing in a health screening cohort in a standing position: Dynamic chest phrenicography. Eur J Radiol. 2019 Apr;113:59-65. doi: 10.1016/j.ejrad.2019.01.034. Epub 2019 Jan 31.

  PMID: 30927960 BACKGROUND

• Yamada Y, Ueyama M, Abe T, Araki T, Abe T, Nishino M, Jinzaki M, Hatabu H, Kudoh S. Difference in diaphragmatic motion during tidal breathing in a standing position between COPD patients and normal subjects: Time-resolved quantitative evaluation using dynamic chest radiography with flat panel detector system ("dynamic X-ray phrenicography"). Eur J Radiol. 2017 Feb;87:76-82. doi: 10.1016/j.ejrad.2016.12.014. Epub 2016 Dec 16.

  PMID: 28065378 BACKGROUND

• Hida T, Yamada Y, Ueyama M, Araki T, Nishino M, Kurosaki A, Jinzaki M, Honda H, Hatabu H, Kudoh S. Decreased and slower diaphragmatic motion during forced breathing in severe COPD patients: Time-resolved quantitative analysis using dynamic chest radiography with a flat panel detector system. Eur J Radiol. 2019 Mar;112:28-36. doi: 10.1016/j.ejrad.2018.12.023. Epub 2019 Jan 4.

  PMID: 30777216 BACKGROUND

MeSH Terms

Conditions

Pulmonary Edema; Pneumonia; Pulmonary Atelectasis; Pleural Effusion; Airway Obstruction; Rib Fractures; Pulmonary Embolism; Hemothorax; Pneumothorax; Mesothelioma; Respiratory Paralysis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Pleural Diseases; Respiratory Insufficiency; Respiration Disorders; Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Gyorgy Frendl, MD PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Hiroto Hatabu, MD PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Bruno Madore, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gyorgy Frendl, MD PhD

CONTACT

617-732-5910; gfrendl@bwh.harvard.edu

Poorva Bagchee, BS

CONTACT

585-203-2857; pbagchee@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The outcomes assessors (radiologists) will evaluate deidentified DDR scans and deidentified traditional x-rays for all study patients in a blinded fashion, and will not be able to compare readings of or diagnoses from each scan for individual patients until after the analysis is complete.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants enrolled in the study will receive the same intervention- there are not separate control and intervention groups. The intervention is a new portably dynamic digital radiography (DDR) scan and will be compared to the patients clinically indicated gold standard diagnostic test (i.e. portable chest x-ray, VQ scan, CT, CT-angio, etc.).

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 5, 2024
• Study Start: December 12, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-08

Locations

US (1)