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

Condition(s) studied

Study summary

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

Primary outcome measure(s)

• SUVmax — through study completion, an average of 1 year
  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 — through study completion, an average of 1 year
  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 — through study completion, an average of 1 year
  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 — through study completion, an average of 1 year
  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)

Trial sites (1)

More Nanjing First Hospital, Nanjing Medical University trials in China

Other trials for the same condition