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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: 68Ga-FL-031 GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Visual and standardized uptake values assessment of lesions and biodistribution

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.

Time frame
1 year

Secondary outcomes

1

Pathological sections of tumour tissue

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

Time frame
1 year

Other outcomes

Sponsors and contacts

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