68Ga-Pentikra PET/CT Imaging Study in Healthy Subjects

Air Force Military Medical University of People's Liberation Army

Status: Active, not recruiting

Conditions: Healthy Volunteers

Treatments: Diagnostic Test: 68Ga-Pentikra PET/CT Scan

Study type: Interventional

Funder types: Other

Identifiers

NCT06856109

KY20252025

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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 .

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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10 participants in 1 patient group

healthy volunteers

Experimental group

Description:

Ten normal volunteers were recruited to perform 68Ga-Pentikra PET/CT imaging to assess the safety, biodistribution and radiation dosimetry of 68Ga-Pentikra.

Treatment:

Diagnostic Test: 68Ga-Pentikra PET/CT Scan