Status:
RECRUITING
Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and Pheochromocytoma/Paraganglioma
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Neuroblastoma
Pheochromocytoma
Eligibility:
All Genders
6+ years
Brief 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...
Detailed Description
This single-center, open-label diagnostic imaging study investigates the clinical utility of somatostatin receptor (SSTR) and norepinephrine transporter (NET) targeted molecular imaging for detection,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 25 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07195500
Start Date
December 25 2024
End Date
June 30 2028
Last Update
September 26 2025
Active Locations (1)
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1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210000