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

NCT05069220 | Recruiting Early Phase 1

• 1 other identifier: ZS-3060MFBG
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Neuroendocrine Tumor; Neuroblastoma; Pheochromocytoma; Paraganglioma

Outcome Measures

Primary Outcomes (1)

• The evaluation of diagnostic performance of 18F-MFBG PET in different regions in metastatic neural crest tumor.

  Patients with histologically confirmed metastatic neural crest tumor will be prospectively recruited in this study. They will receive 18F-MFBG PETand 123I-MIBG SPECT. Rate of detected lesions (visual) in bone, lymph node and liver will be compared.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Assessment of lesion targeting by 18F-MFBG as compared to 68Ga-DOTATATE

  through study completion, an average of 2 years

Study Arms (1)

18F-MFBG PET/CT in neuroendocrine malignancies

EXPERIMENTAL

Each patient receive a single intravenous injection of 18F-MFBG 2-4 MBq/kg and undergo PET/CT scan after 60 min post-injection. Patients with neuroblastoma should have a routine clinical 123I-MIBG scintigraphy (planar and/or SPECT/CT) performed within 6 months prior to the inclusion visit or scheduled within 3 months after the inclusion visit. According to patients' condition and clinical management, part of patients with PPGL and NB will receive 68Ga-DOTATATE PET/CT, comparing with 18F-MFBG PET/CT.

Drug: 18F-MFBG; Drug: 68Ga-Dotatate

Interventions

18F-MFBG DRUG

Patients with neuroendocrine malignancies receive 2-4 MBq/kg of 18F-MFBG intravenously followed by PET/CT after 60min of injection.

Also known as: 18F-metafluorobenzylguanidine

18F-MFBG PET/CT in neuroendocrine malignancies

68Ga-Dotatate DRUG

Patients with malignant PPGL and NB receive intravenously 68Ga-Dotatate followed by PET/CT after 40min of injection.

18F-MFBG PET/CT in neuroendocrine malignancies

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• 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.

You may not qualify if:

• \- Patients are potentially pregnant (serum and urinary hCG test will be performed in women where pregnancy is not excluded) or is breast-feeding.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking union medical college hospital

Beijing, Dongcheng, 100010, China

RECRUITING

Related Publications (2)

• Wang P, Yu S, Chen X, Zheng X, Mao J, Jing H, Zhuang H, Li F, Su X. [18F]MFBG PET/CT is an effective and preferable imaging modality for neuroblastoma in a prospective comparison with SSTR PET. Eur J Nucl Med Mol Imaging. 2025 Jul 28. doi: 10.1007/s00259-025-07449-y. Online ahead of print.

  PMID: 40717185 DERIVED

• Wang P, Li T, Liu Z, Jin M, Su Y, Zhang J, Jing H, Zhuang H, Li F. [18F]MFBG PET/CT outperforming [123I]MIBG SPECT/CT in the evaluation of neuroblastoma. Eur J Nucl Med Mol Imaging. 2023 Aug;50(10):3097-3106. doi: 10.1007/s00259-023-06221-4. Epub 2023 May 9.

  PMID: 37160439 DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors; Neuroblastoma; Pheochromocytoma; Paraganglioma

Interventions

3-fluorobenzylguanidine; gallium Ga 68 dotatate

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neoplasms, Glandular and Epithelial

Study Officials

• Fang Li

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peipei Wang

CONTACT

18511395988; wpp199411@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 6, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

CN (1)