Clinical trial NCT02348749: 18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies
Official title: A Phase I/IIA Study of 18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neuroendocrine Tumors
Keywords: 18F-MFBG Imaging
14-138
PET/MR
PET/CT scan
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 48
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: For phase I, a single dose of 18F-MFBG will be injected intravenously in patients. For all patients, pharmacokinetics and bio distribution will be evaluated using non invasive PET scanning and blood assays at multiple time points post injection. In the expansion phase, a single dose of 18F-MFBG will be injected intravenously followed by a single time point imaging using PET MR or PET/CT scanner
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see how a new tracer named 18F-MFBG (Meta Fluorobenzyl Guanidine) behaves in the body after injection, how it spreads to all the organs and how it is removed from the body. We will also study how long 18F-MFBG lasts in the blood after administered. In addition we want to study if 18F-MFBG can show Neuroendocrine tumors on a PET-CT or PET MR scan.


Eligibility criteria: 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 prior MIBG-avid disease and evaluable disease on MIBG scan at the time of enrollment onto the protocol.

  * If MIBG scan is available within 4 weeks of MFBG, with no intervening treatment, MIBG scan will not be repeated.
  * If prior MIBG scan is available \>4 weeks of MFBG, MIBG scan will be done within a week (prior or after) of MFBG.
* 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.
* Patients with positive lesion detection by 18F-MFBG may be eligible for repeat imaging scan, at the discretion of PI or study investigator(s).

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, who are not already undergoing anesthesia for standard-of-care procedures.

Primary outcomes:
measure: dosimetry of 18F MFBG
timeFrame: 1 year
measure: radioactivity
timeFrame: 1 year
Secondary outcomes:
measure: 18 F-MFBG imaging PET/CT to target known sites of disease
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Neeta Pandit-Taskar, MD
role: PRINCIPAL_INVESTIGATOR
References: