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NCT Number: NCT06688305

68Ga-NI-FAPI PET/CT: First-in-human Study

68Ga-NI-FAPI is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI PET/CT 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

Location contact

Jie Zang, PhD, MD

CONTACT

[email protected]

86-0591-87981619

Weibing Miao, MD

CONTACT

[email protected]

MD 86-0591-87981618

About this study

Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, and showed high efficacy in tumor staging and restaging. 68Ga-NI-FAPI is a novel agent incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI in patients with different types of cancer.

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-NI-FAPI

Drug

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-NI-FAPI.

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-NI-FAPI. The dose delivered to normal organs and tumors will be recorded.

Other outcomes

  1. Diagnostic value

    Time frame: through study completion, an average of 3 months

    Sensitivity and Specificity of 68Ga-NI-FAPI for patients with various cancers.

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Zang, MD

CONTACT

[email protected]

+86-0591-87981619

Weibing Miao, MD

CONTACT

[email protected]

+86-0591-87981618

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title

68Ga-NI-FAPI PET/CT: First-in-human 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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