18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies

Inclusion Criteria:

Phase I:

- Eligible patients include patients with histologically proven Neuroendocrine tumors
(paraganglioma, PHEO, or well differentiated NET of the lung or GI system) or NB.
Patients who have NB, the diagnosis must be in accordance with the International
Criteria, i.e., either histopathology or bone marrow involvement. Patients must be ≥5
years of age and able to undergo PET scan without sedation

- All patients must have MIBG-avid disease and evaluable disease on MIBG scan at the
time of enrollment onto the protocol.

- Performance status of ≥60 on Karnofsky scale for patients >16 years of age and >60 on
Lansky scale for patients <16 years of age.

- Cardiac, pulmonary, gastrointestinal and neurologic toxicity should all be ≤grade 2.

Expansion Cohort:

- Patients with diagnosis of NB (in accordance with the International Criteria, i.e.,
either histopathology or bone marrow involvement)

- Patients must be able to undergo PET scan without sedation

- Patients must have MIBG-avid disease and evaluable disease on MIBG scan at the time of
enrollment onto the protocol.

- Performance status of ≥60 on Karnofsky scale for patients >16 years of age and >60 on
Lansky scale for patients ≤16 years of age.

- Cardiac, pulmonary, gastrointestinal and neurologic toxicity should all be ≤grade 2.

Exclusion Criteria:

- Major organ toxicity including cardiac, pulmonary, gastrointestinal and neurologic
toxicity more than grade 2.

- Active serious infections not controlled by antibiotics.

- Inability or unwillingness to undergo PET scanning

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Women who are pregnant or breastfeeding.

- Patient has an active malignancy of metastatic potential other than the known NE tumor
for the past 3 years.

- Patients should not have received chemotherapy or radiation therapy (localized
radiation therapy is allowed to non-evaluable sites) between prior 123I-MIBG scan and
18F-MFBG administration.

- Patients requiring anesthesia