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NCT03541720
18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma
EARLY_PHASE1 trial testing 18F-DA in Neuroblastoma in 13 participants. Participants enrolled and being followed up; not accepting new ones.
1 January 2027
Quick facts
| Lead sponsor | St. Jude Children's Research Hospital |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 13 |
| Start date | 30 April 2019 |
| Primary completion | 1 January 2027 |
| Estimated completion | 1 July 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 18F-DA — full drug profile →
Conditions studied
- Neuroblastoma — all drugs for Neuroblastoma →
- Pheochromocytoma — all drugs for Pheochromocytoma →
Sponsor
St. Jude Children's Research Hospital
Who can join
1 and older, any sex, with Neuroblastoma or Pheochromocytoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
PET (positron emission tomography) scans combined with a radioactive tracer will be used to identify and analyze tumors. Currently, the most common tracer used to analyze neuroblastoma tumors is called 123I-mIBG. However, the picture it provides is not always clear enough to see the very small areas of the disease. 18F-DA (18F-fluorodopamine) has been shown to be safe and more effective than 123I-mIBG in analyzing the tumor pheochromocytoma, which is closely related to neuroblastoma. With this research study, the investigators plan to meet the following goals: * Investigate to see if 18F-DA is safe to administer to pediatric patients with known or suspected neuroblastoma or pheochromocytoma * Examine where in the body 18F-DA goes. * Obtain information comparing 18F-DA to 123I-mIBG to see if 18F-DA could replace 123I-mIBG in the future. About 20 people, with known or suspected neuroblastoma or pheochromocytoma, will take part in this Pilot study at St. Jude.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pathways and challenges in the clinical translational of radiopharmaceuticals for pediatric investigations.
Stauff E, Karimi H, Kecskemethy HH, Shaffer TH, et al · · 2025 · PMID 41282032 · DOI 10.3389/fmed.2025.1658588
Verify or expand the search:
- PubMed search for NCT03541720
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT07067346 — Safety & Efficacy of IR-101 in Relapsed/Refractory Neuroblastoma · EARLY_PHASE1 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03541720 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by St. Jude Children's Research Hospital
- Last refreshed: 3 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03541720.
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