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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: lxl730724@hotmail.com
• Phone: 86-027-83692633

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.