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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy volunteers | Experimental | Ten normal volunteers were recruited to perform 68Ga-Pentikra PET/CT imaging to assess the safety, biodistribution and radiation dosimetry of 68Ga-Pentikra. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-Pentikra PET/CT Scan | Diagnostic Test | 68Ga-Pentikra Injection, Intravenous, administered at 0.05 mCi/kg by weight. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Standardized uptake value | 68Maximum standardised uptake values of Ga-Pentikra in regions of interest (ROIs) of the heart, lungs, liver, kidneys, spleen and brain in healthy subjects | 1 day from injection of the tracer |
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Inclusion Criteria:
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 .
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China, Xi'an, Shaanxi Province | Xi'an | Shaanxi | China |
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