68Ga-FL-031 PET for diagnosing and staging cancer

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

This project will test whether 68Ga-FL-031 PET imaging, compared with 18F-FDG PET, can detect and stage small cell lung cancer, breast cancer, nasopharyngeal carcinoma and other tumors in adults.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07301801 on ClinicalTrials.gov

What this trial studies

This early-phase, single-center study will enroll adults with suspected or confirmed small cell lung cancer, breast cancer, nasopharyngeal carcinoma, or other tumors to undergo both 68Ga-FL-031 PET and standard 18F-FDG PET imaging. Histopathology from biopsy or surgical specimens will be used as the reference standard to confirm presence or absence of lesions and metastatic status. The trial will compare lesion detection, localization, and staging performance between the two tracers and quantify 68Ga-FL-031 uptake values. Correlation between PET uptake and tumor SSTR2 expression by immunohistochemistry will be analyzed to explore target-specific imaging utility.

Who should consider this trial

Good fit: Adults (18+) with suspected or pathologically confirmed small cell lung cancer, breast cancer, nasopharyngeal carcinoma, or other tumors who can give informed consent and cooperate with imaging procedures.

Not a fit: Patients who cannot provide informed consent, who are unable to cooperate with imaging, who are medically unstable, or whose tumors do not express SSTR2 are unlikely to benefit from this imaging approach.

Why it matters

Potential benefit: If successful, 68Ga-FL-031 PET could improve detection and staging of tumors and help identify patients whose tumors express SSTR2 for targeted therapies.

How similar studies have performed: SSTR2-targeted PET tracers such as 68Ga-DOTATATE are well established in neuroendocrine tumors, but applying a novel tracer like 68Ga-FL-031 to these other cancers is relatively untested.

Eligibility 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:

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.

Where this trial is running

Wuhan, Hubei

• Wuhan Union Hospital — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Xiaoli Lan — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Xiaoli Lan, Professor

Conditions Malignant Tumors; SSTR2; PET