Loading clinical trials...

18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies

A Phase I/IIA Study of 18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies

NCT02348749•Memorial Sloan Kettering Cancer Center

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

Age

5 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

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.

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

January 1, 2015

Primary Completion Date

March 17, 2025

Completion Date

March 17, 2025

Last Updated

March 19, 2025

Enrollment

ACTUAL participants

Conditions

Neuroendocrine Tumors

Interventions

18F-MFBG (meta-fluoro benzylguanidine)

RADIATION

Positron emission tomography (PET) imaging

DEVICE

Blood draws

OTHER

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

NCT05746208

Neuroendocrine TumorsWell-Differentiated Neuroendocrine Carcinoma+1 more

View study

RECRUITINGPHASE2

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

NCT06228066

Small Cell Carcinoma of the BladderHigh Grade Neuroendocrine Tumors of the Urinary Tract

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies

Inclusion Criteria

Exclusion Criteria

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors

F-Tryptophan PET/CT in Human Cancers

SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET)

A Study of BL-M14D1 in Patients With Locally Advanced or Metastatic Small Cell Lung Cancer, Neuroendocrine Tumors and Other Solid Tumors