Recruiting

CT Scan

Sponsor:

Massachusetts General Hospital

Code:

NCT07527117

Conditions

Pulmonary Embolism (Diagnosis)

Pulmonary Embolism Acute

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT07527117

Start date

Jul 15, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients who decline informed consent
2. Patients with known chronic PE
3. Patients with known interstitial lung diseases
4. Patients who cannot raise their arms above their shoulders (arms can cause serious artifacts)
5. Women of child-bearing potential (< 55 years) who test positive for pregnancy test
6. Patients < 21 years of age (to avoid research radiation dose in young patients)
7. 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.
8. Pregnant subjects
9. Women of child-bearing potential (21-55 years) who refuse to take a urine pregnancy test prior to their CT examination
10. Mini Mental State Exam (MMSE) score of less than 18.

Study Design

Enrollment

750 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Non-contrast CT for diagnosis of acute pulmonary embolism

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.

Interventions

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

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

Primary outcome measure

  • NPV for ruling out PE on non-contrast CT [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Shivangi JHA, MD, MPH

16176434583sjha7@mgh.harvard.edu

Locations

Massachusetts General Hospital/Harvard Medical School

Recruiting

Boston, Massachusetts, United States, 02420

Contacts

MANNUDEEP K KALRA, MD

617-543-2623mkalra@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

  • CT ventilation perfusion pulmonary embolism CT pulmonary angiogram

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-09-11.