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NCT Number: NCT06688188

68Ga-JH12 PET/CT: Dosimetry and Biodistribution Study

68Ga-JH12 is a novel radiotracer targeting C-X-C motif chemokine receptor 4 (CXCR4). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH12 in patients with different types of cancer.

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Key information

Conditions

Malignant Neoplasm Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location status: Recruiting

About this study

C-X-C motif chemokine receptor 4 (CXCR4) is highly expressed in patients affected with malignant tumors and ex-vivo analyses provided evidence that the expression level on the tumor cell surface is tightly linked to the proliferation index. In recent years, the diagnostic PET agent 68Ga-Pentixafor targeting this chemokine receptor has been extensively validated in haematological malignancies and solid tumors. 68Ga-JH12, a novel radiopharmaceutical targeting CXCR4, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, the safety, biodistribution, and radiation dosimetry of 68Ga-JH12 in patients with Various Cancers were observed to evaluate the dosimetric characteristics of 68Ga-JH12.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Various solid tumors with available histopathological findings
  • Signed informed consent

Exclusion criteria

  • pregnant or lactational women
  • who suffered from severe hepatic and renal insufficiency

Treatment and study plan

68Ga-JH12

Drug

The dose will be 148-222 MBq given intravenously.

Primary outcomes

  1. safety and tolerability

    Time frame: up to 1 week

    Hematologic status, liver function, renal function and General vital signs were recorded before and 1 week after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.

Secondary outcomes

  1. Dosimetry of normal organs and tumors

    Time frame: From right after tracer injection to 150 minutes at post-injection

    The semiquantitative dosimetry will be performed based on PET/CT acquisitions after the first administration of 68Ga-JH12. The dose delivered to normal organs and tumors will be recorded.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title

68Ga-JH12 PET/CT: Dosimetry and Biodistribution Study in Patients With Various Cancers

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2024
Registry last updated
Nov 14, 2024

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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