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

NCT ID: NCT06538376

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-12
• Study Completion Date: 2027-11-30

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.

Detailed Description

Chest radiography was introduced to medical practice over a century ago, shortly after the discovery of X-rays by Roentgen. Since then, it has been a key component of the health, screening, clinical evaluation, and the assessments of therapy for billions of people. To this day, chest radiography remains the most frequently ordered imaging test. In this 700-bed tertiary care hospital, over 100,000 chest radiographs are obtained annually. The technique of chest radiography has remained largely unchanged and is seen as a mostly qualitative rather than quantitative tool. Chest dynamic X-ray (DDR) is a new advanced version of chest radiography that provides important quantitative parameters such as lung motion, ventilation, and perfusion. With a dynamic scan of 20-30 seconds, sequential images of both lungs are obtained with high temporal resolution during breathing (7.5-30 frames per second), without increasing radiation dose. DDR utilizes a dynamic digital radiography (DDR) technique with a flat-panel detector (2-6) and generates images with a field-of-view (FOV) that can cover both lungs. DDR utilizes detectors with higher sensitivity than those typically used in conventional radiography, enabling multiple dynamic time frames to be obtained despite keeping the dose mostly unchanged. Compared to conventional radiography, computer analysis and image processing of the DDR sequential time frames provide additional valuable metrics that capture motion and other key functions of the lungs, while high-quality chest radiographs can also be generated from the recombined frames. Chest DDR can be performed in essentially any patient position, including standing or sitting, to capture lung physiology in a manner representative of daily life. Furthermore, DDR is inexpensive, requires minimal space, and enables high throughput, which can help reduce medical costs. While area-detector CT can provide a higher temporal resolution, its FOV cannot entirely cover both lungs and its radiation dose can be prohibitively high. Chest DDR offers a unique opportunity to provide dynamic imaging parameters for lung motion and function in a safe, practical, and cost-effective manner.

Recently, the portable DDR technology has become available. This portable DDR scanner enables applications for non-mobile patients, like ICU patients. It allows the semi-quantitative or quantitative evaluation of pulmonary perfusion, ventilation, and diaphragmatic motion. ICU patients may have limited access to CT or MRI scanners due to the severity of their condition and/or to difficulties associated with support their devices (ECMO, LVAD, etc.), hence, why the portable DDR technology could have an especially meaningful impact on their care. The current Radiology team consists of Drs. Nishino, Wada, Valtchinov and Madore. The PI's group from Radiology will work in close collaboration with Dr. Frendl's research team in the BWH ICUs, as well as their biostatistician as multidisciplinary team of experts. They will also continue cooperation with Mr. Tsunomori and Mr. Yoneyama. These team members already have an established track record of successful collaboration with the PI.

The investigators will use the observational study design where two diagnostic imaging modalities will be compared for their ability to best diagnose lung pathologies (i.e., diaphragmatic motion and lung aeration/ventilation, pulmonary perfusion, and lung water content). These imaging modalities are: (i) the current portable AP chest x-ray (CXR)-based diagnostic technique and (ii) the recently developed portable dynamic chest XR (DDR) technique.

The DDR technology has yet to be proven to provide specific benefits for the care of the patients through the improved diagnosis of their pulmonary issues. Its ability to provide clinically meaningful additional information on aspects of lung pathologies (diaphragmatic motion and lung aeration/ventilation, pulmonary perfusion, and lung water content), that cannot be clearly discerned from the current portable CXR-based diagnostic technique, need to be documented; hence, the aims.

This study design will compare the ability to diagnose those lung pathologies (atelectasis, pulmonary embolus, and pulmonary edema) as determined by either the DDR technology or the traditional qualitative portable routine AP CXR (the current standards of diagnosis) through images obtained via the two techniques at the same time points for each patient. The DDR imaging and analysis will provide both qualitative and semi-quantitative data for each patient at all time points.

For this study, the patient's routine portable CXR will serve as the control image when applicable, and DDR images will serve as study images for each timepoint. For certain clinical conditions, the applicable gold standards will be used as controls, i.e. CT angiogram for pulmonary embolus, V-Q scans for lung ventilation and perfusion, and fluorographic swallowing studies for speech and swallow evaluation.

Data derived from these studies will be expected to provide novel and clinically crucial (quantitative or semi-quantitative) information on the degree of diaphragmatic excursion when the patient is spontaneously ventilating vs. when ventilator support is provided. This would be crucial for decision making regarding the patient's readiness for extubation, or, inversely, when poor excursion of the diaphragms is detected for non-ventilated patients, it would support the decision for early implementation of ventilator support. Data on lung aeration would also factor into this decision-making process.

Currently, quantitative or semi-quantitative data regarding these physiologic functions of the lungs are not available. Hence, why the investigators will focus on validating these novel metrics against clinical scenarios and outcomes. The investigators anticipate that this novel technology will better guide clinical decision making like the need for (or inversely, the safe removal of) ongoing ventilator support for our patients.

Furthermore, the perfusion (blood flow assessment) component of the image analysis would provide invaluable (currently unavailable) diagnostic options for those patients for whom CT angiogram is not available to rule out/confirm pulmonary embolism (PE). CT angiogram is not available for patients who suffer from hemodynamic instability, or when it is clinically contraindicated, like patients with impending renal failure. The added value of the DDR technology for the diagnosis of larger PEs will be assessed in the later stages of this study.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Portable Dynamic Digital Radiography (DDR)

Intervention Type: 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.

Interventions

Portable Dynamic Digital Radiography (DDR)

(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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konica Minolta

UNKNOWN

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gyorgy Frendl, M.D., Ph.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gyorgy Frendl, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Hiroto Hatabu, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Bruno Madore, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gyorgy Frendl, MD PhD

Role: CONTACT

gfrendl@bwh.harvard.edu

617-732-5910

Poorva Bagchee, BS

Role: CONTACT

pbagchee@bwh.harvard.edu

585-203-2857

Facility Contacts

Gyorgy Frendl, MD, PhD

Role: primary

gfrendl@bwh.harvard.edu

6177325910

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

2023P001100

Identifier Type: -

Identifier Source: org_study_id