Not Yet Recruiting

NCT Number: NCT07527117

Role of n On-contrast Chest CT (NCCT) Based CT V: Q in Patients With Acute Pulmonary Embolism (aPE)

We are doing the research to see if a CT scan without the dye can help find pulmonary emboli. If you agree to join the study, you will be asked to sign this consent form before we do any research procedures. If you join the research, we will ask you to blow into a small device known as a spirometer to train you to hold your breath after you inhale and exhale. Spirometer is a small handheld device to find out how well your lungs work when you inhale and exhale. For this research, we will obtain two extra sets of CT images at very low levels of radiation dose. The two extra sets of images will take less than 1 minute. Your total participation time is about 5 minutes. We will also review your medical record for up to 30 to 90 days after your CT scan.

The main risks of being in the study are exposure to ionizing radiation which may have health risks, and minor inconvenience from the spirometer test.

You will not benefit from taking part in this research study. If you take part in this study, your participation may help people in the future. If you decide not to be in the study, you will still have the standard-of-care chest CT with the dye ordered by your doctor. You will not be paid for taking part in this research study.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pulmonary Embolism (Diagnosis) Cardiovascular Diseases Disease Embolism Embolism and Thrombosis Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Pulmonary Embolism Acute Respiratory Tract Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02420, United States

Location contact

Shivangi JHA, MD MPH

CONTACT

[email protected]

6176434583

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients undergoing CTPA for suspected aPE
Patients who provide written informed consent to participate
Adults patients >/= 21 years of age
Mini Mental State Exam (MMSE) score of 18 or more.

Exclusion criteria

Patients who decline informed consent
Patients with known chronic PE
Patients with known interstitial lung diseases
Patients who cannot raise their arms above their shoulders (arms can cause serious artifacts)
Women of child-bearing potential (< 55 years) who test positive for pregnancy test
Patients < 21 years of age (to avoid research radiation dose in young patients)
Patients with any EMR documented cognitive impairment or diseases such as dementia, recent head injury, psychiatric disorders, or other neurological diseases that impair decision-making.
Pregnant subjects
Women of child-bearing potential (21-55 years) who refuse to take a urine pregnancy test prior to their CT examination
Mini Mental State Exam (MMSE) score of less than 18.

Treatment and study plan

Additional CT acquisition at low dose (1- 2 mSv)

Diagnostic Test

In addition to their CTPA, we will acquire low-dose CT images in inspiration and expiration breath hold or in free breathing phase.

Other names: CT

Primary outcomes

NPV for ruling out PE on non-contrast CT

Time frame: 2 years

Negative predictive value

Study contacts

Contact information is provided by the study sponsor or research team.

Shivangi JHA, MD, MPH

CONTACT

[email protected]

16176434583

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Apr 14, 2026
Registry last updated: Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting