NET- and somatostatin-targeted PET/SPECT imaging to find and stage neuroblastoma and pheochromocytoma/paraganglioma
the Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for the Diagnosis and Staging of Neuroblastoma and Pheochromocytoma/Paraganglioma
This study will try different PET and SPECT tracers to see if they can accurately find and stage tumors in children and adults with neuroblastoma or pheochromocytoma/paraganglioma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07195500 on ClinicalTrials.gov |
What this trial studies
This single-center, open-label diagnostic imaging effort compares multiple norepinephrine transporter (NET) and somatostatin receptor (SSTR) tracers (for example 18F-MFBG, 123I/131I-MIBG, and 68Ga-DOTA-peptides) using PET/CT, PET/MRI, and SPECT/CT to detect primary and metastatic disease. Image acquisition and reconstruction are harmonized and quantitative imaging metrics will be recorded. Imaging findings will be compared against a composite reference standard including histopathology when available and multidisciplinary clinical adjudication. A predefined subset may undergo two different tracer scans within a short window to directly compare tracer performance for staging and treatment planning.
Who should consider this trial
Good fit: Ideal candidates are people (from infancy onward) with suspected or confirmed neuroblastoma or pheochromocytoma/paraganglioma who need molecular imaging for staging, restaging, recurrence workup, or treatment planning and can undergo PET or SPECT imaging and provide informed consent.
Not a fit: Patients who are pregnant or breastfeeding, those with contraindications to MRI (for the PET/MRI subset), or those for whom imaging results would not change clinical management are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the work could improve detection and staging accuracy and help tailor treatment plans by identifying sites of primary and metastatic disease more reliably.
How similar studies have performed: Related tracers such as MIBG and 68Ga-DOTA-peptides are already used clinically with documented utility, while newer agents like 18F-MFBG have shown promising preliminary results but are less widely established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Provision of written informed consent/assent per local regulations. * Women of childbearing potential: negative pregnancy test within 72 hours prior to tracer administration and agreement to use effective contraception during the imaging window. * For the multi-tracer subset (if applicable): willingness to undergo two imaging studies within a predefined window (e.g., ≤28 days) without intervening antitumor therapy. Exclusion Criteria: * 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. * Use of interfering medications without feasible washout: NET imaging: drugs that affect catecholamine transport/storage (e.g., labetalol, tricyclic antidepressants, certain sympathomimetics) per site SOPs. SSTR imaging: long-acting somatostatin analogues within \~3-4 weeks or short-acting within \~24-48 hours, unless clinically unavoidable. * 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. * Contraindications to required modality-specific procedures (e.g., MRI-incompatible implants for PET/MRI; iodinated/gadolinium contrast contraindication only if contrast is mandated and no alternative pathway is acceptable). * Inability to lie still for the required acquisition time and sedation not feasible per institutional policy. * Concurrent participation in an interventional study or receipt of anticancer therapy that would confound imaging interpretation within the imaging window; for multi-tracer comparisons, any interval systemic therapy between scans.
Where this trial is running
Nanjing, Jiangsu
- Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Guoqiang Shao, Dr
- Email: guoqiangshao@163.com
- Phone: +86 153 6615 5689
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.