18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma

NCT03541720 | Active Not Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: FLOPETNCI-2018-01306
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuroblastoma; Pheochromocytoma

Outcome Measures

Primary Outcomes (1)

• Adverse event rate

  The adverse events will be recorded and monitored up to two days after the injection of radiotracer 18F-DA. The 95% CI for the adverse event rate will be calculated and reported. If one adverse event grade 2 or above, attributable to study drug, the study will be stopped until completion of IRB review and a decision about whether the study should be modified or closed.

  up to 2 days following injection of the radiotracer 18F-DA.

Secondary Outcomes (2)

• The frequency of localization of 18F-DA in different organs.

  up to half year following injection of the radiotracer 18F-DA.

• max SUV from 18F-DA and 123I-mIBG PET

  up to half year following injection of the radiotracer 18F-DA.

Other Outcomes (1)

• Mean and standard deviation of the difference of Curie scoring of 18F-DA and 123I-mIBG imaging

  up to half year following injection of the radiotracer 18F-DA.

Study Arms (1)

Injection of 18F-DA

EXPERIMENTAL

18F-DA will be injected into a vein in the arm or leg, or via central venous access line.

Drug: 18F-DA

Interventions

18F-DA DRUG

18F-DA is an investigational PET radiotracer

Injection of 18F-DA

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with known or suspected neuroblastoma or pheochromocytoma are eligible. 18F-DA PET/CT scanning will not be the initial imaging study in a newly diagnosed patient.
• Patients with positive findings on prior imaging within the past 4 weeks are eligible.
• Prior therapy is allowed.
• Patients \> 1 year of age, under the care of a SJCRH physician.
• Patients of both genders, and all ethnic groups, under the care of a SJCRH physician.
• Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.
• Informed consent signed by participant, parent, or guardian according to the guidelines of the institutional review board.
• Patients may undergo a repeat study one or more years following the initial FLOPET scan.

You may not qualify if:

• Inability or unwillingness of patient, parent, or guardian to consent.
• Pregnancy or lactation. Future plans for pregnancy do not exclude patient participation. Patients should not become pregnant within one month of completion of 18F-DA PET scan.
• Use of medications known to interfere with 123I-mIBG uptake (principal considerations are phenylephrine and pseudoephedrine containing compounds which need to be discontinued for 48 hours, and labetalol which needs to be discontinued for 6 weeks).
• Patients less than 3 years of age who require a total length of anesthesia time greater than 3 hours (for the FLOPET scan in conjunction with another clinical procedure requiring sedation) will be excluded from the study.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38119, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Neuroblastoma; Pheochromocytoma

Interventions

6-fluorodopamine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Paraganglioma; Neuroendocrine Tumors

Study Officials

• Barry Shulkin, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 18F-DA scans will be performed within 4 weeks of standard imaging evaluations, such as CT (computed tomography) and I-123mIBG scanning. 18F-DA will be injected into a vein in the arm or leg, or via central venous access line.

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 30, 2018
• Study Start: April 30, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)