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NCT Number: NCT07301801

Clinical Application of 68Ga-FL-031 PET in the Diagnosis and Staging of Malignant Tumors

The project's objective is to recruit patients with clinically confirmed or suspected small cell lung cancer, breast cancer, nasopharyngeal carcinoma and other tumours for 68Ga-FL-031 PET imaging and 18F-FDG PET imaging. The histopathology of biopsy or surgical specimens was taken as the final diagnostic criteria, and the presence or absence of tumour lesions was confirmed by the aforementioned imaging. The location and nature of the lesion, and the presence or absence of metastasis, were then judged. The objective was to analyse and clarify the diagnostic efficacy of 68Ga-FL-031 PET imaging for the aforementioned malignant tumours. The objective of this study is to analyse the correlation between the 68Ga-FL-031 PET imaging tumour tissue uptake value and the tumour tissue immunohistochemical staining SSTR2 target expression.

Recruiting

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Key information

Conditions

Malignant Tumors Neoplasms PET SSTR2

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The subject or their legal representative is permitted to sign the informed consent form.
  • The subject has committed themselves to adherence to the prescribed research procedures and to cooperation in the implementation of the entire study process.
  • Adult patients (aged 18 years or older), irrespective of gender
  • Patients with a clinical suspicion or confirmed diagnosis of small cell lung cancer, breast cancer, nasopharyngeal carcinoma, and other tumours (for which supporting evidence is provided in the form of serum-related tumour markers, ultrasound, CT, MRI and other image data, and histopathological examination)
  • The patient is generally in good condition
  • It is mutually agreed upon by all parties involved that the designated specimen shall be utilised for the purposes of this study.

Exclusion criteria

  • The patient or his legal representative is unable or unwilling to sign the informed consent
  • The patient is unable to cooperate with the implementation of the whole process research
  • The patient has been diagnosed with acute systemic diseases and electrolyte disorders
  • Pregnant women or lactating women, etc
  • In the event of other circumstances being deemed by the investigator to be unsuitable for participation in the study, such patients must be excluded on the basis of their known intolerance to SSTR2 targeted substances.

Treatment and study plan

Injection of 68Ga-FL-031

Drug

Patients will be injected with 68Ga-FL-031and PET imaging was performed at different time points

Injection of 18F-FDG

Drug

Patients will be injected with 18F-FDG and PET imaging was performed

Primary outcomes

  1. Visual and standardized uptake values assessment of lesions and biodistribution

    Time frame: 1 year

    At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of tumor and normal organs will be measured and the semiquantitative analysis is conducted for each patient.

Secondary outcomes

  1. Pathological sections of tumour tissue

    Time frame: 1 year

    The tumor tissue was taken for immunohistochemistry to verify its SSTR2 expression

Study contacts

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

Xiaoli Lan, Professor

CONTACT

[email protected]

86-027-83692633

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Dec 24, 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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