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Clinical application of 111In-FL-031 SPECT in the diagnosis and staging of malignant tumors

Clinical application of 111In-FL-031 SPECT in the diagnosis and staging of malignant tumors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128454
Enrollment
Unknown
Registered
2026-07-21
Start date
2026-03-24
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Small cell lung cancer, breast cancer, nasopharyngeal carcinoma and other malignant tumors

Interventions

Gold Standard:Pathological specimens or follow-up of existing lesions in patients
Index test:[111In] In-FL-031 SPECT/CT imaging experiment and [18F] FDG PET/CT imaging experiment

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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 frame
Tumor to background ratio (TBR);maximum standard uptake value (SUVmax);Mean standard uptake value (SUVmean);Sensitivity;Specificity;Negative Predictive Value;Positive Predictive Value;Youden’s index;ROC curve and AUC;Accuracy;

Secondary

MeasureTime frame
Expression content of SSTR2 targets in lesions;

Countries

China

Contacts

Public ContactXiaoli Lan

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

hzslxl@163.com+86 27 85726685

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026