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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07301801
Enrollment
10
Registered
2025-12-24
Start date
2025-06-12
Completion date
2026-09-30
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Tumors, SSTR2, PET

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.

Interventions

DRUGInjection of 68Ga-FL-031

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

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

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. The subject or their legal representative is permitted to sign the informed consent form. 2. The subject has committed themselves to adherence to the prescribed research procedures and to cooperation in the implementation of the entire study process. 3. Adult patients (aged 18 years or older), irrespective of gender 4. 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) 5. The patient is generally in good condition 6. It is mutually agreed upon by all parties involved that the designated specimen shall be utilised for the purposes of this study.

Exclusion criteria

1. The patient or his legal representative is unable or unwilling to sign the informed consent 2. The patient is unable to cooperate with the implementation of the whole process research 3. The patient has been diagnosed with acute systemic diseases and electrolyte disorders 4. Pregnant women or lactating women, etc 5. 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.

Design outcomes

Primary

MeasureTime frameDescription
Visual and standardized uptake values assessment of lesions and biodistribution1 yearAt 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

MeasureTime frameDescription
Pathological sections of tumour tissue1 yearThe tumor tissue was taken for immunohistochemistry to verify its SSTR2 expression

Countries

China

Contacts

Primary ContactXiaoli Lan, Professor
lxl730724@hotmail.com86-027-83692633

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026