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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07527117
Status
Not Yet Recruiting

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Conditions

  • Pulmonary Embolism (Diagnosis)
  • Pulmonary Embolism Acute

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
750 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02420
Shivangi JHA, MD MPH
6176434583

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