EXPLORER PET/CT in Healthy Volunteers

Healthy Clinical Trial

Official title:

EXPLORER PET/CT: A Pilot Evaluation in Healthy Volunteers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04110743
• Other study ID #: 1341792
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: December 19, 2023

Study information

• Verified date: August 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women, 18 years of age or older

• Willing and able to fast for at least 6 hours before and for the duration of the scan

• Willing and able to lay motionless in a supine position for 60 and 20 minutes at separate timepoints.

• Willing and able to give informed consent

Exclusion Criteria:

• No Primary Care Physician

• Body weight >240 kg

• Allergy to iodine contrast (only for subjects enrolled in Arm 3)

• Creatinine levels > 1.5 mg/dL or estimated glomerular filtration rate (eGFR) < 60 ml/minute (only for subjects enrolled in Arm 3)

• Recent (1 month) contrast enhanced CT

• 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 > 160 mg/dL before administration of FDG

• Prisoners

• The standard MRI contraindications apply, including but not limited to:

Having a pacemaker or other implanted electronic device. Metal foreign bodies, aneurysm clips, heart valve prosthesis, vascular stents, cochlear implants, embolization coils, gunshot wounds with retained bullet fragments, penile implant, IUCD.

Claustrophobia

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• EXPLORER PET/CT
Intervention: PET/CT using different protocols

Locations

Country	Name	City	State
United States	University of California, Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized Uptake Value SUV(t)= C(t)/ID/BW C(t) is radioactivity measured at the time t, decay corrected to t=0 and converted from a volume to a mass based unit via the factor 1/(1 g/mL) ID: the injected dose at t=0 BW= Body weight	To collect preliminary data regarding FDG biodistribution as a function of time. Time-activity curves will be created	approximatively 12 hours
Primary	Coefficient of variation. SD/mean (Standard deviation divided by mean value)	To obtain preliminary data regarding low dose EXPLORER noise level	approximatively 3 hours
Primary	Standardized Uptake Value	To collect preliminary data about total body FDG perfusion and early biodistribution. Time-activity curves will be created	approximatively 1 hour
Primary	Standardized Uptake Value SUV(t)= C(t)/(ID/BW) C(t) is radioactivity measured from an image at the time t, decay corrected to t=0 and converted from a volume to a mass based unit via the factor 1/(1 g/mL) ID: the injected dose at t=0 BW= Body weight	To obtain preliminary data to understand whether intravenous iodinated contrast agent produce a significant change in quantification of FDG uptake levels.; Time/activity curves will be generated.	approximatively 2 hours