Healthy Subjects (HS)Early Phase 1NCT07604207
Multi-organ Imaging of Microvascular and Metabolic Function
A Early Phase 1 study testing 18F-FDG and Positron Emission Tomography (PET) in people with Healthy Subjects (HS) and Cardiovascular Diseases (CVD), run by Massachusetts General Hospital.
Trial summary
What if heart disease starts outside the heart? This research will study how to simultaneously assess brain and body physiology, how they are jointly related to heart function, and how their response to physical and mental stress differs in patients with heart disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects (HS), Cardiovascular Diseases (CVD)
- What is being tested?
- 18F-FDG and Positron Emission Tomography (PET)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jul 2031
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- For patients with cardiovascular disease: Documented diagnosis of ischemic heart disease based on standard clinical, radiologic, and/or histopathologic criteria, as documented in the medical record; or a clinical nuclear cardiac stress PET test within 1 year.
- For healthy subjects: No diagnosis of cardiometabolic disease, cancer, or other major disease within the past 5 years
Who cannot join
- Contraindications to PET due to:
- Research-related radiation exposure exceeding current MGB Radiology Department guidelines (i.e., 50 mSv in the prior 12 months);
- Inability to lie comfortably on the bed inside the scanner;
- Body weight > 300 lbs (weight limit of the scanner table);
- Pregnancy or breastfeeding;
- Individuals with fasting plasma glucose level of >200 mg/dL;
- Claustrophobia
- Employed under the direct supervision of the PI conducting the research.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
What if heart disease starts outside the heart? This research will study how to simultaneously assess brain and body physiology, how they are jointly related to heart function, and how their response to physical and mental stress differs in patients with heart disease.
- Being tested
- 18F-FDG, Positron Emission Tomography (PET)
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGDrug
Dynamic 18F-FDG PET
Positron Emission Tomography (PET)Device
Panorama GS PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Dynamic PET/CT scan | Experimental | Each subject will undergo one or more dynamic PET/CT scans with various acute stressors Receives: Drug: 18F-FDG; Device: Positron Emission Tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow responses
The primary endpoint is to evaluate if blood flow responses to acute stressors can be quantitatively measured with 18F-FDG
Measured: During the procedure
Secondary outcomes (1)
Glucose metabolism responses
The secondary endpoint is to evaluate if glucose metabolic responses to acute stressors can be quantitatively measured with 18F-FDG
Measured: During the scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startJan 2027 (estimated)
- Primary completionJul 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects (HS)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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will undergo PET/CT scan(s) at rest and under a physical or mental stimuli
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin, Chung, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604207
- Sponsor's protocol ID
- 2026P001016
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-organ Imaging of Microvascular and Metabolic Function
- ClinicalTrials.gov ID
- NCT07604207
- Acronym / sponsor ID
- 2026P001016
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 22 May 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.
What if heart disease starts outside the heart? This research will study how to simultaneously assess brain and body physiology, how they are jointly related to heart function, and how their response to physical and mental stress differs in patients with heart disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will undergo PET/CT scan(s) at rest and under a physical or mental stimuli
| Arm | Type | Receives |
|---|---|---|
| Dynamic PET/CT scan | Experimental | Drug: 18F-FDG, Device: Positron Emission Tomography (PET)Each subject will undergo one or more dynamic PET/CT scans with various acute stressors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years and older
- For patients with cardiovascular disease: Documented diagnosis of ischemic heart disease based on standard clinical, radiologic, and/or histopathologic criteria, as documented in the medical record; or a clinical nuclear cardiac stress PET test within 1 year.
- For healthy subjects: No diagnosis of cardiometabolic disease, cancer, or other major disease within the past 5 years
Key exclusion criteria (8 listed)
- Contraindications to PET due to:
- Individuals with fasting plasma glucose level of >200 mg/dL;
- Claustrophobia
- Employed under the direct supervision of the PI conducting the research.
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 |
|---|---|---|
| 18F-FDGDynamic 18F-FDG PET | Drug | Dynamic PET/CT scan |
| Positron Emission Tomography (PET)Panorama GS PET/CT | Device | Dynamic PET/CT scan |
Primary outcome
Blood flow responses
Time frame: During the procedure
The primary endpoint is to evaluate if blood flow responses to acute stressors can be quantitatively measured with 18F-FDG
1 secondary outcome
Glucose metabolism responses
Time frame: During the scan
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 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-FDG and Positron Emission Tomography (PET) in people with Healthy Subjects (HS) and Cardiovascular Diseases (CVD), run by Massachusetts General Hospital.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kevin J. Chung, PhD (617-724-9232, kchung0@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow responses (time frame: During the procedure). 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 28 Oct 2026.