Multi-organ Imaging of Microvascular and Metabolic Function

NCT07604207 | Not Yet Recruiting Early Phase 1 FDA Drug FDA Device

• 1 other identifier: 2026P001016
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Subjects (HS); Cardiovascular Diseases (CVD)

Outcome Measures

Primary Outcomes (1)

• Blood flow responses

  The primary endpoint is to evaluate if blood flow responses to acute stressors can be quantitatively measured with 18F-FDG

  During the procedure

Secondary Outcomes (1)

• Glucose metabolism responses

  During the scan

Study Arms (1)

Dynamic PET/CT scan

EXPERIMENTAL

Each subject will undergo one or more dynamic PET/CT scans with various acute stressors

Drug: 18F-FDG; Device: Positron Emission Tomography (PET)

Interventions

18F-FDG DRUG

Dynamic 18F-FDG PET

Dynamic PET/CT scan

Positron Emission Tomography (PET) DEVICE

Panorama GS PET/CT

Dynamic PET/CT scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Fluorodeoxyglucose F18; Positron-Emission Tomography

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Central Study Contacts

Kevin J. Chung, PhD

CONTACT

617-724-9232; kchung0@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Model Details: Participants will undergo PET/CT scan(s) at rest and under a physical or mental stimuli

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share