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

NCT06856109 | Active Not Recruiting

• 1 other identifier: KY20252025
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Diagnostic Test: 68Ga-Pentikra PET/CT Scan

Interventions

68Ga-Pentikra PET/CT Scan DIAGNOSTIC_TEST

68Ga-Pentikra Injection, Intravenous, administered at 0.05 mCi/kg by weight.

healthy volunteers

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) 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.

You may not qualify if:

• \- 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).
• \) Previous history of tumour and surgery; 3) Other conditions judged by the investigator to be unsuitable as study subjects .

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China, Xi'an, Shaanxi Province

Xi'an, Shaanxi, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: February 10, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)