Role of n On-contrast Chest CT (NCCT) Based CT V: Q in Pa... | NCT07527117

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

NCT07527117

Sponsor

Massachusetts General Hospital

Status

Not yet recruiting

Last Update Posted

Apr 14, 2026Actual

Enrollment

750Estimated

Phase

Not Applicable

Conditions

Pulmonary Embolism (Diagnosis)
Pulmonary Embolism Acute

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Jun 30, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Apr 7, 2026

First Submission Date that Met QC Criteria

Apr 7, 2026

First Posted Date

Apr 14, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2026

Last Update Posted Date

Apr 14, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

750Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NPV for ruling out PE on non-contrast CT	Negative predictive value	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shivangi JHA, MD, MPH	Contact	16176434583		sjha7@mgh.harvard.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02420	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

To protect patient privacy and comply with hospital guidelines, we will not share IPD.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011655	Pulmonary Embolism
D004194	Disease

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis

Browse Leaves

Not provided

Browse Branches

Not provided