NCT07301801 Clinical Application of 68Ga-FL-031 PET in the Diagnosis and Staging of Malignant Tumors
| NCT ID | NCT07301801 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Malignant Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-06-12 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-06-12 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Xiaoli Lan
PRINCIPAL INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT07301801 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07301801 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07301801 currently recruiting?
Yes, NCT07301801 is actively recruiting participants. Contact the research team at lxl730724@hotmail.com for enrollment information.
Where is the NCT07301801 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07301801 clinical trial?
NCT07301801 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The principal investigator is Xiaoli Lan at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 10 participants.