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

NCT07301801 | Recruiting Early Phase 1

• 1 other identifier: XLan-0603
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Tumors; PET; SSTR2

Outcome Measures

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.

  1 year

Secondary Outcomes (1)

• Pathological sections of tumour tissue

  1 year

Study Arms (1)

68Ga-FL-031 Group

EXPERIMENTAL

This is one diagnostic study. Firstly, oncologists screen patients with malignant tumors such as small cell lung cancer, breast cancer, head and neck cancer and so on, who are clinically suspected or confirmed. Secondly, investigators will talk to patients who meet the inclusion criteria, explain the study purpose and process; the patients are required to sign informed consent forms, and receive the 18F-FDG and 68Ga-FL-031PET scanning respectively in outpatient or inpatient periods. Thirdly, general information, clinical data, blood routine, urine routine, liver and kidney function and other biochemical indicators, electrocardiogram, radionuclide imaging results and other imaging data of the patients participating in the study were collected and compared with histopathology to evaluate the value of both imaging in the diagnosis of the above mentioned malignant tumors.

Drug: Injection of 68Ga-FL-031; Drug: Injection of 18F-FDG

Interventions

Injection of 68Ga-FL-031 DRUG

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

68Ga-FL-031 Group

Injection of 18F-FDG DRUG

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

68Ga-FL-031 Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Xiaoli Lan

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoli Lan, Professor

CONTACT

86-027-83692633; lxl730724@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

CN (1)