Pulmonary Embolism (Diagnosis)NCT07527117
Role of n On-contrast Chest CT (NCCT) Based CT V: Q in Patients With Acute Pulmonary Embolism (aPE)
A study testing Additional CT acquisition at low dose (1- 2 mSv) in people with Pulmonary Embolism (Diagnosis) and Pulmonary Embolism Acute, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pulmonary Embolism (Diagnosis), Pulmonary Embolism Acute
- What is being tested?
- Additional CT acquisition at low dose (1- 2 mSv)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital/Harvard Medical School
Boston, Massachusetts, 02420
MANNUDEEP K KALRA, MD, 617-543-2623, mkalra@mgh.harvard.edu
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02420
Shivangi JHA, MD MPH, 617-643-4583, sjha7@mgh.harvard.edu
About this study
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.
- Being tested
- Additional CT acquisition at low dose (1- 2 mSv)
- Keywords
- CT ventilation perfusion pulmonary embolism CT pulmonary angiogram
- Medical subject headings
- Pulmonary Embolism, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional CT acquisition at low dose (1- 2 mSv)Diagnostic test
Also called CT
In addition to their CTPA, we will acquire low-dose CT images in inspiration and expiration breath hold or in free breathing phase.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Additional CT acquisition at low dose (1- 2 mSv) |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPV for ruling out PE on non-contrast CT
Negative predictive value
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start15 Jul 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mannudeep,Kalra, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527117
- Sponsor's protocol ID
- 2026P000652
- Status last verified
- Sep 2026
- First submitted
- 7 Apr 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: To protect patient privacy and comply with hospital guidelines, we will not share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of n On-contrast Chest CT (NCCT) Based CT V: Q in Patients With Acute Pulmonary Embolism (aPE)
- ClinicalTrials.gov ID
- NCT07527117
- Acronym / sponsor ID
- 2026P000652
- Keywords
- CT ventilation perfusion pulmonary embolism CT pulmonary angiogram
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-contrast CT for diagnosis of acute pulmonary embolism | Experimental | Diagnostic Test: Additional CT acquisition at low dose (1- 2 mSv)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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional CT acquisition at low dose (1- 2 mSv)Also: CTIn addition to their CTPA, we will acquire low-dose CT images in inspiration and expiration breath hold or in free breathing phase. | Diagnostic test | Non-contrast CT for diagnosis of acute pulmonary embolism |
Primary outcome
NPV for ruling out PE on non-contrast CT
Time frame: 2 years
Negative predictive value
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided. To protect patient privacy and comply with hospital guidelines, we will not share IPD.
Related trials for Pulmonary Embolism (Diagnosis)
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional CT acquisition at low dose (1- 2 mSv) in people with Pulmonary Embolism (Diagnosis) and Pulmonary Embolism Acute, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shivangi JHA, MD, MPH (16176434583, sjha7@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPV for ruling out PE on non-contrast CT (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.