18F-MFBG PET/CT in the Evaluation of Neuroendocrine Malignancies

  • STATUS
    Recruiting
  • End date
    Sep 14, 2023
  • participants needed
    50
  • sponsor
    Peking Union Medical College Hospital
Updated on 14 October 2021

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).

Description

Pheochromocytoma and paraganglioma (PPGL) and neuroblastoma (NB) highly express norepinephrine transporter (NET) which is targeted by functional analogue of norepinephrine, 131I/123I-MIBG. However, low spatial resolution of 123/131I-MIBG and inaccurate attenuation correction of single photon emission tomography (SPECT/CT) will affect the image quality of MIBG SPECT and lead to poor diagnosis of small lesions. In addition, 123I-MIBG imaging is usually performed at 24 h after injection, while 131I-MIBG is performed at 48 h or even 72 h after injection. The procedure is complicated and takes a long time, which limits clinical application. 18F-labeled MFBG is an ideal tracer to show the expression of NET. Preliminary data show that 18F-MFBG imaging is safe and has favorable biodistribution and kinetics with good targeting of lesions. Patients can undergo PET 0.5 hours after injection without special preparation. Our study will assess the safety profile, image quality and evaluate the diagnostic performance and tumor burden of 18F-MFBG. Patients with histologically confirmed multifocal and/or metastatic neural crest tumor will be prospectively recruited in this study.

Details
Condition neuroendocrine tumour, Neurectoderma, Neuroendocrine Tumor, neuroendocrine tumors, Neuroectodermal Tumor
Treatment 18F-MFBG, 18F-MFBG
Clinical Study IdentifierNCT05069220
SponsorPeking Union Medical College Hospital
Last Modified on14 October 2021

Eligibility

Yes No Not Sure

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 multifocal and/or metastatic neural crest tumor
Subject should have a routine clinical 131I-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
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