EXPLORER PET/CT: Evaluation of Healthy Individuals From Racial/Ethnic Minority Populations

NCT ID: NCT04812080

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-18
• Study Completion Date: 2021-11-08

Brief Summary

The objective of this pilot study is to collect preliminary data using total body scans on a new, first of its kind, FDA 510k-cleared positron emission tomography/computed tomography (PET/CT) scanner, called EXPLORER. The study will aim to recruit healthy individuals from racial/ethnic minority populations.

Detailed Description

The aim of this pilot study is to increase the number of healthy individuals from racial/ethnic minority populations. This will advance research being conducted at EMIC by providing "controls" or comparisons to differentiate between images from patients with cancer versus healthy people of the same racial/ethnic ancestry. In addition, blood samples from participants to this study will be utilized for quantitative, genetics-based estimates of ancestry (e.g., African, Chinese, Colombian, Western European, Mexican, Vietnamese, etc.), which is especially valuable in the case of admixed individuals.

Conditions

Healthy Volunteers From Racial/Ethnic Minority Populations

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

EXPLORER PET/CT Imaging

Study participants will be injected with 10 +/- 2 mCi of 18F-FDG using and IV line and a 60 minute PET scan will begin on EXPLORER. Prior to the PET scan, an ultra-low-dose CT scan (less than 1 minute ) will be acquired for attenuation correction purposes only. Ninety (90) minutes after being injected with FDG, participants will have another ultra-low dose CT scan (less than 1 minute) which will be acquired for attenuation correction purposes only. This will be followed by a 20 minute PET scan on EXPLORER. One-hundred and twenty (120) minutes after being injected with FDG, participants will be positioned supine on the scanner table for the last time. At this time, a low dose CT scan (less than 1 minute) will be acquired once again for attenuation correction purposes. This will be followed by one last 20 minute PET scan on EXPLORER. The IV line will be removed after completion of the study.

Group Type: EXPERIMENTAL

EXPLORER PET/CT

Intervention Type: DEVICE

FDG PET Scans on the total body EXPLORER PET/CT scanner

Interventions

EXPLORER PET/CT

FDG PET Scans on the total body EXPLORER PET/CT scanner

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Men and women, 18 years of age or older
• Member of a Federally recognized racial/ethnic minority population, e.g., African American or Black; Hispanic or Latino; Asian American; Native Hawaiian or Other Pacific Islander; Native American or Alaska Native
• Willing and able to fast for at least 6 hours before and for the duration of the scan
• Willing to provide urine samples throughout scan visit
• Willing to provide blood samples for ancestry analysis
• Willing and able to lay motionless in a supine position for up to 60 minutes and for up to 20 minutes at two separate timepoints
• Willing and able to give informed consent, personal contact information (phone number, email and postal address), insurance information, and primary care physician contact

Exclusion Criteria

• No Primary Care Physician
• No health insurance
• Body weight more than 240 kg (529 pounds)
• Any known concomitant acute infection (including upper respiratory infection, genitourinary infections, etc.)
• History of metastatic or newly (last 5 years) diagnosed locally invasive cancer
• Chemotherapy in the last 5 years
• Radiation therapy in the last 3 years
• Major surgery within the last 6 months
• Pregnancy or breast-feeding
• Diabetes
• Fasting blood glucose level > 200 mg/dL before administration of fluorodeoxyglucose (FDG)
• Prisoners
• Self-reported history of dysphoria or anxiety in closed spaces

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moon Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis

Sacramento, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1714742

Identifier Type: -

Identifier Source: org_study_id