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
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.
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.
This single-center cohort comprises pediatric and adult patients with suspected or confirmed neuroblastoma (NB) or pheochromocytoma/paraganglioma (PPGL) who are referred for somatostatin receptor (SSTR) and/or norepinephrine transporter (NET)-targeted molecular imaging as part of diagnostic evaluation, staging, restaging, suspected recurrence assessment, response evaluation, or treatment planning (e.g., selection for peptide receptor radionuclide therapy or 131I-MIBG therapy). Participants are enrolled primarily from oncology, endocrinology, and nuclear medicine clinics of a tertiary academic medical center, with referrals from affiliated hospitals; most imaging is performed in the outpatient setting, with inpatient cases included when clinically indicated. Both sexes and all racial/ethnic groups are eligible, reflecting the catchment population. The study population includes a prespecified subset undergoing multi-tracer imaging when clinically justified and feasible, and a PET/MRI su
Cohort
Prospective
Not listed
SUVmax
SUVmax is obtained by outlining a 3-D volume of interest (VOI) around the lesion on attenuation-corrected PET images; the software reports the single voxel with the highest activity concentration, normalized to injected tracer dose divided by the patient's body weight (MBq/kg).
SUVmean
SUVmean is obtained by outlining a 3-D volume-of-interest around the lesion on attenuation-corrected PET images and averaging all voxel values. Standardized uptake values are calculated as voxel activity concentration (kBq/mL) divided by injected activity per body weight (kBq/g).
Diagnostic Accuracy of SSTR and NET-Targeted Imaging
Per-patient and per-lesion sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy compared to composite reference standard (histopathology when available and/or multidisciplinary clinical adjudication) Area under the receiver operating characteristic curve (AUC-ROC) for quantitative uptake metrics (SUVmax, SUVmean, target-to-background ratios)
Comparative Diagnostic Performance Between Tracer Classes
Head-to-head comparison of NET-targeted tracers (18F-MFBG, 123I-MIBG, others) versus SSTR-targeted tracers (68Ga-DOTA-peptides, 64Cu-DOTATATE, 18F-SSTR agents, others) in patients undergoing multi-tracer imaging Within-class comparative performance (e.g., 68Ga-DOTATATE vs 68Ga-DOTATOC vs 68Ga-DOTANOC; 18F-MFBG vs 123I-MIBG)
Inter-reader Agreement
Cohen's kappa coefficient and percent agreement between two blinded readers for lesion detection and characterization Intraclass correlation coefficient for quantitative uptake measurements
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