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

NCT07527117 | Not Yet Recruiting FDA Device

• 1 other identifier: 2026P000652
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Embolism (Diagnosis); Pulmonary Embolism Acute

Keywords

CT ventilation perfusion pulmonary embolism CT pulmonary angiogram

Outcome Measures

Primary Outcomes (1)

• NPV for ruling out PE on non-contrast CT

  Negative predictive value

  2 years

Study Arms (1)

Non-contrast CT for diagnosis of acute pulmonary embolism

EXPERIMENTAL

Patients will undergo an additional low dose CT image acquistion without contrast prior to CT pulmanary angiogram. The low dose CT will be performed in both inspiration and expiration.

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

Interventions

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.

Also known as: CT

Non-contrast CT for diagnosis of acute pulmonary embolism

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02420, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism; Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shivangi JHA, MD, MPH

CONTACT

16176434583; sjha7@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology, Attending Radiologist

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)