Clinical trial NCT03541720: 18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma
Official title: 18F-Fluorodopamine PET Studies of Neuroblastoma and Pheochromocytoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Neuroblastoma
Pheochromocytoma
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

Detailed description: Neuroblastoma is the most common extracranial malignant tumor of childhood. Nuclear imaging with 123I-mIBG is the standard test to follow and manage these patients. Because of the inherent imaging characteristics of I-123, there is suboptimal resolution within the images, causing them to appear somewhat blurry, which reduces our ability to find small areas of disease. A chemical that uses positron emission tomography should allow much better resolution of the images, which could improve patient care by allowing us to find small areas of disease that, if untreated, could result in tumor relapse. We have developed 18F-fluorodopamine (18F-DA) for PET imaging in our patients with neuroblastoma.

The primary objective is to explore the safety of 18F-DA in patients with known or suspected neuroblastoma or pheochromocytoma. The secondary objectives are to evaluate the biodistribution of 18F-DA in patients with neuroblastoma and compare the biodistribution of 18F-DA with the biodistribution of 123I-mIBG.

Patients receive an intravenous injection of a small (tracer) dose of 18F-DA. Approximately 1 hour later, patients undergo PET scanning of the entire body to evaluate the localization of the tracer.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Adverse event rate
timeFrame: up to 2 days following injection of the radiotracer 18F-DA.
Secondary outcomes:
measure: The frequency of localization of 18F-DA in different organs.
timeFrame: up to half year following injection of the radiotracer 18F-DA.
measure: max SUV from 18F-DA and 123I-mIBG PET
timeFrame: up to half year following injection of the radiotracer 18F-DA.
Other outcomes:
measure: Mean and standard deviation of the difference of Curie scoring of 18F-DA and 123I-mIBG imaging
timeFrame: up to half year following injection of the radiotracer 18F-DA.
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Barry Shulkin, MD
role: PRINCIPAL_INVESTIGATOR
References: