Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT06538376

Conditions

Pulmonary Edema

Pneumonia

Atelectasis

Pleural Effusion

Acute Rejection of Lung Transplant (Disorder)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Portable Dynamic Digital Radiography (DDR)

Study Details

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)

Study ID

NCT06538376

Start date

Dec 12, 2023

Status verified date

Aug, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria: Participants must meet all the following inclusion criteria to participate in this study:

  • 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: Candidates meeting any of the exclusion criteria at baseline will be excluded from study participation. These criteria are:

  • 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.

Study Design

Enrollment

230 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • 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. [ 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. [ Time Frame: Up to 2 months ]

Central Contacts and Locations

Central contacts

Gyorgy Frendl, MD PhD

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

Poorva Bagchee, BS

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

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Gyorgy Frendl, MD, PhD

6177325910gfrendl@bwh.harvard.edu

Principal Investigator:

Gyorgy Frendl, MD, PhD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Oct 29, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-10-29.