NET- and somatostatin-targeted PET/SPECT imaging to find and stage neuroblastoma and pheochromocytoma/paraganglioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nanjing First Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Guoqiang Shao, Dr
• Email: guoqiangshao@163.com
• Phone: +86 153 6615 5689

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using 18F-MFBG PET/CT to evaluate neural crest tumors

  This study is testing a new imaging method using 18F-MFBG to see if it can help diagnose and better understand tumors like pheochromocytoma, paraganglioma, and neuroblastoma in patients.

  Recruiting Early Phase 1 Peking Union Medical College Hospital · Beijing, Dongcheng · NCT05069220

• Combining Lutathera® and Olaparib for treating recurrent solid tumors in children and adolescents

  This study is testing if combining Lutathera® with olaparib can help children and teenagers with hard-to-treat solid tumors that have certain receptors.

  Recruiting Phase 1/2 Fundación de investigación HM · Boadilla del Monte, Madrid · NCT06607692

• Registry for Rare Diseases

  This study is creating a detailed registry to collect information on rare diseases like amyloidosis and sarcoidosis to help improve how they are diagnosed and treated.

  Recruiting Hospital Italiano de Buenos Aires · Buenos Aires, Buenos Aires · NCT06573723

• Understanding genetic causes of neuroendocrine tumors in Mexican patients

  This study is trying to find out the genetic changes that cause neuroendocrine tumors in Mexican patients to help develop better treatments.

  Recruiting at 3 sites Universidad Nacional Autonoma de Mexico · Mexico City, Mexico City and 2 other locations · NCT06523582

• Examining the immune system in hereditary pheochromocytoma and paraganglioma

  This study is testing how the immune system works in people with pheochromocytoma and paraganglioma, especially those with a family history of these tumors, to see if it can help us find better treatments.

  Recruiting Radboud University Medical Center · Nijmegen, Gelderland · NCT06444607

• Advancing genomic medicine using electronic health records

  This study is trying to see if using electronic health records and helpful reminders can get more patients tested for genetic conditions in a way that doctors can easily use.

  Recruiting University of Pennsylvania · Philadelphia, Pennsylvania · NCT06377033

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.