Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and Pheochromocytoma/Paraganglioma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorNanjing First Hospital, Nanjing Medical University

About this trial

The goal of this clinical trial is to evaluate the diagnostic efficacy of somatostatin receptor and norepinephrine transporter targeted imaging (including 18F-MFBG, 123I-MIBG, 131I-MIBG, 68Ga-DOTA-NOC, 68Ga-DOTA-TATE, 68Ga-DOTA-TOC, and other radiolabeled somatostatin analogues) in the diagnosis and staging of neuroblastoma and pheochromocytoma/paraganglioma patients aged 1-70 years. The main questions it aims to answer are:

Can molecular targeted imaging using various norepinephrine transporter tracers (18F-MFBG, 123I/131I-MIBG) and somatostatin receptor tracers (68Ga-DOTA-peptides series) accurately detect primary tumors and metastatic lesions in neuroblastoma/pheochromocytoma patients? What is the comparative diagnostic performance (sensitivity, specificity, accuracy) of different molecular imaging techniques compared to histopathological diagnosis as the gold standard? Researchers will compare the imaging findings from multiple tracer types with surgical pathology results to assess diagnostic accuracy and clinical staging precision.

Participants will:

* Undergo screening assessments including medical history, physical examination, and laboratory tests * Receive intravenous injection of selected tracers (18F-MFBG, 68Ga-DOTA-NOC/TATE, or other appropriate agents) at standardized doses followed by PET-CT/MRI imaging at optimal time points * Undergo histopathological examination within 2 months post-imaging * Complete safety follow-up for 6 months to monitor for any adverse reactions to the imaging agents

Eligibility criteria

Qualifiers

Age: ≥6 months (pediatric and adult).

Suspected or confirmed diagnosis of neuroblastoma (NB) or pheochromocytoma/paraganglioma (PPGL).

Clinical indication for SSTR and/or NET-targeted molecular imaging for initial staging, restaging, suspected recurrence, response assessment, or treatment planning.

Ability to undergo PET/CT or PET/MRI and/or SPECT/CT per protocol; for the PET/MRI subset, no MRI contraindications.

Disqualifiers

Pregnant or breastfeeding; breastfeeding participants unwilling to follow tracer-specific lactation interruption guidance per institutional policy.

Any condition that, in the investigator's judgment, precludes safe imaging or protocol compliance (e.g., uncontrolled cardiorespiratory disease, severe claustrophobia not amenable to sedation/anxiolysis).

Known hypersensitivity to study radiopharmaceuticals or their excipients.

Prior therapeutic or high-dose 131I-MIBG within a period that would confound diagnostic imaging or dosimetry (e.g., within 6 months), at the investigator's discretion.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

30 Participants
are grouped into 1 trial group