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Active, Not Recruiting

NCT Number: NCT06856109

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Xi'an, Shaanxi, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

68Ga-Pentikra PET/CT Scan

Diagnostic Test

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

Primary outcomes

  1. Maximum Standardized uptake value

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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