Healthy Volunteers From Racial/Ethnic Minority Populations
Conditions
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.
Interventions
DEVICEEXPLORER PET/CT
FDG PET Scans on the total body EXPLORER PET/CT scanner
Sponsors
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | 3 hours | To collect preliminary data about total body FDG perfusion and early biodistribution in a cohort of racial/ethnic minority volunteers as measured by standardized uptake value (SUV) in gm/ml reported as Mean and Standard Deviation. The SUV is the ratio of the image-derived radioactivity concentration and the whole body concentration of the infected radioactivity. |
| Count of Participants With Confirmed Ancestry Informative Markers | 15 minutes | Participants' self-reported racial/ethnic identity and ancestral origin confirmation with Ancestry Informative Markers (AIMS) analysis |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMoon Chen, PhD
University of California, Davis
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
EXPLORER PET/CT: FDG PET Scans on the total body EXPLORER PET/CT scanner | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | EXPLORER PET/CT Imaging |
|---|---|
| Age, Continuous | 51.52 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Count of Participants With Confirmed Ancestry Informative Markers
Participants' self-reported racial/ethnic identity and ancestral origin confirmation with Ancestry Informative Markers (AIMS) analysis
Time frame: 15 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EXPLORER PET/CT Imaging | Count of Participants With Confirmed Ancestry Informative Markers | 20 Participants |
Primary
Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation
To collect preliminary data about total body FDG perfusion and early biodistribution in a cohort of racial/ethnic minority volunteers as measured by standardized uptake value (SUV) in gm/ml reported as Mean and Standard Deviation. The SUV is the ratio of the image-derived radioactivity concentration and the whole body concentration of the infected radioactivity.
Time frame: 3 hours
Population: All the participants completed their scheduled scans at three timepoints: dynamic scan for 60 minutes, two scans at 90- and 120-minutes post-injection, for 20-minutes each.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Brain @ 40 minutes | 7.293 gm/ml | Standard Deviation 1.678 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Brain @ 90 minutes | 5.157 gm/ml | Standard Deviation 1.323 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Brain @ 120 minutes | 4.429 gm/ml | Standard Deviation 1.141 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Aorta @ 40 minutes | 2.357 gm/ml | Standard Deviation 0.208 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Aorta @ 90 minutes | 1.039 gm/ml | Standard Deviation 0.123 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Aorta @ 120 minutes | 0.794 gm/ml | Standard Deviation 0.089 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Liver @ 40 minutes | 2.639 gm/ml | Standard Deviation 0.285 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Liver @ 90 minutes | 1.215 gm/ml | Standard Deviation 0.156 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Liver @ 120 minutes | 0.966 gm/ml | Standard Deviation 0.109 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Spleen @ 40 minutes | 2.029 gm/ml | Standard Deviation 0.254 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Spleen @ 90 minutes | 1.019 gm/ml | Standard Deviation 0.13 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Spleen @ 120 minutes | 0.846 gm/ml | Standard Deviation 0.13 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Vertebrae @ 40 minutes | 1.380 gm/ml | Standard Deviation 0.186 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Vertebrae @ 90 minutes | 0.839 gm/ml | Standard Deviation 0.137 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Vertebrae @ 120 minutes | 0.712 gm/ml | Standard Deviation 0.125 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Skeletal muscle @ 40 minutes | 0.768 gm/ml | Standard Deviation 0.068 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Skeletal muscle @ 90 minutes | 0.425 gm/ml | Standard Deviation 0.052 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Skeletal muscle @ 120 minutes | 0.353 gm/ml | Standard Deviation 0.049 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Subcutaneous fat @ 40 minutes | 0.451 gm/ml | Standard Deviation 0.078 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Subcutaneous fat @ 90 minutes | 0.207 gm/ml | Standard Deviation 0.037 |
| EXPLORER PET/CT Imaging | Standardized Uptake Value (SUV) in gm/ml Reported as Mean and Standard Deviation | Subcutaneous fat @ 120 minutes | 0.155 gm/ml | Standard Deviation 0.027 |