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Recruiting EARLY_Phase 1 NCT05069220

NCT05069220 18F-MFBG PET/CT in the Evaluation of Neural Crest Tumor

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Clinical Trial Summary
NCT ID NCT05069220
Status Recruiting
Phase EARLY_Phase 1
Sponsor Peking Union Medical College Hospital
Condition Neuroendocrine Tumor
Study Type INTERVENTIONAL
Enrollment 150 participants
Start Date 2021-09-01
Primary Completion 2025-09

Eligibility & Interventions

Sex All sexes
Min Age 1 Year
Max Age 80 Years
Study Type INTERVENTIONAL
Interventions
18F-MFBG68Ga-Dotatate

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

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 150 participants in total. It began in 2021-09-01 with a primary completion date of 2025-09.

⚠ 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 aim of this study is to evaluate the diagnostic performance and tumor burden of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients with neuroendocrine tumors mainly in pheochromocytoma and paraganglioma (PPGL) and neuroblastoma (NB).

Eligibility Criteria

Inclusion Criteria: \- The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed. Patients with histologically confirmed or clinically suspicious neural crest tumor. For patients with neuroblastoma, subject should have a routine clinical 123I-MIBG scintigraphy (planar + SPECT/CT) performed within 6 months prior to the inclusion visit or scheduled within 3 months after the inclusion visit. The subject is male or is a nonpregnant, nonlactating female who is either surgically sterile or is post-menopausal. The subject is able and willing to comply with all study procedures as described in the protocol. Exclusion Criteria: \- Patients are potentially pregnant (serum and urinary hCG test will be performed in women where pregnancy is not excluded) or is breast-feeding. Patients undergo surgery between the selection and inclusion visit. Patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating. Patients who are not suitable to participate in the trial according to researchers.

Contact & Investigator

Central Contact

Peipei Wang

✉ wpp199411@163.com

📞 18511395988

Principal Investigator

Fang Li

PRINCIPAL INVESTIGATOR

Peking Union Medical College Hospital

Frequently Asked Questions

Who can join the NCT05069220 clinical trial?

This trial is open to participants of all sexes, aged 1 Year or older, up to 80 Years, studying Neuroendocrine Tumor. 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 NCT05069220 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 NCT05069220 currently recruiting?

Yes, NCT05069220 is actively recruiting participants. Contact the research team at wpp199411@163.com for enrollment information.

Where is the NCT05069220 trial being conducted?

This trial is being conducted at Beijing, China.

Who is sponsoring the NCT05069220 clinical trial?

NCT05069220 is sponsored by Peking Union Medical College Hospital. The principal investigator is Fang Li at Peking Union Medical College Hospital. The trial plans to enroll 150 participants.

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