Healthy Volunteers
Conditions
Brief summary
This is a prospective, interventional clinical pilot study that recruited 10 normal volunteers who underwent 68Ga-Pentikra PET/CT imaging to evaluate the safety, biodistribution and radiation dosimetry of 68Ga-Pentikra in normal volunteers.
Interventions
DIAGNOSTIC_TEST68Ga-Pentikra PET/CT Scan
68Ga-Pentikra Injection, Intravenous, administered at 0.05 mCi/kg by weight.
Sponsors
Xijing Hospital
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\) Age: 18 \ 60 years old (including boundary values); 2) Gender: male or female; 3) Body weight: males weighing ≥50kg, females weighing ≥45kg, and body mass index \[BMI = weight (kg)/height 2 (m2)\] within the range of 19.0 \ 26.0kg/m2 (including boundary values); (4) Subjects can fully understand and voluntarily participate in this experiment, and sign the informed consent form.
Exclusion criteria
\- 1) Minors, pregnant women, lactating women, and those with severe hepatic or renal insufficiency (alanine aminotransferase exceeding the upper limit of normal values by 8-10 times and serum creatinine of 186-442 umol/L). 2\) Previous history of tumour and surgery; 3) Other conditions judged by the investigator to be unsuitable as study subjects .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Standardized uptake value | 1 day from injection of the tracer | 68Maximum standardised uptake values of Ga-Pentikra in regions of interest (ROIs) of the heart, lungs, liver, kidneys, spleen and brain in healthy subjects |
Countries
China
Outcome results
None listed