An interventional study of Portable Dynamic Digital Radiography (DDR) in Pulmonary Edema, Pneumonia and Atelectasis, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-29.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
126 studies on the registry are indexed under Pulmonary Edema; 27 are open to participants now.
This study's planned enrollment of 230 is above the median of 65 across 62 interventional studies indexed under Pulmonary Edema.
Browse Pulmonary Edema studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Participants must meet all the following inclusion criteria to participate in this study:
Exclusion Criteria: Candidates meeting any of the exclusion criteria at baseline will be excluded from study participation. These criteria are:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
(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.
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.
Time frame: 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
Time frame: Up to 2 months
Started Dec 2023 (actual). Primary completion is estimated for Nov 2026, 35 months after the start.
Of 22 interventional studies with no phase under Pulmonary Edema, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 69. This study's planned 35 months is below that.
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