ClinicalTrials.gg
RecruitingNCT07527117Updated Sep 11, 2026

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

An interventional study of Additional CT acquisition at low dose (1- 2 mSv) in Pulmonary Embolism (Diagnosis) and Pulmonary Embolism Acute, sponsored by Massachusetts General Hospital. Recruiting at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
750
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Embolism (Diagnosis)
  • Pulmonary Embolism Acute

Keywords

  • CT ventilation perfusion pulmonary embolism CT pulmonary angiogram
03

In context

Pulmonary Embolism

832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.

This study's planned enrollment of 750 is above the median of 174 across 429 interventional studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients who decline
  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 (\< 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. (MMSE) score of less than 18.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
750 participants (estimated)

Study 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.

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

Interventions

  • Diagnostic testAdditional 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.

    Also known as: CT

06

What researchers measure

Primary outcomes

  1. NPV for ruling out PE on non-contrast CT

    Negative predictive value

    Time frame: 2 years

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — To protect patient privacy and comply with hospital guidelines, we will not share IPD.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Jun 2028, 23 months after the start.

Of 125 non-industry interventional studies with no phase under Pulmonary Embolism, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 55. This study's planned 23 months is below that.

Counting every sponsor, half of 150 studies reached it within 25 months; a quarter within 15 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2026
First posted
Apr 14, 2026
StartActual
Jul 15, 2026
Primary completionEst.
Jun 30, 2028
CompletionEst.
Dec 31, 2028
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07527117
Responsible party
Mannudeep,Kalra (Professor of Radiology, Attending Radiologist, Massachusetts General Hospital) — Principal investigator
First posted
Apr 14, 2026
Start date
Jul 15, 2026
Primary completion
Jun 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 11, 2026

Study contacts

Shivangi JHA, MD, MPH
Contact
sjha7@mgh.harvard.edu
16176434583

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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