18F-MFBG PET/CT in the Evaluation of Neural Crest Tumor

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Sep 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called 18F-MFBG PET/CT to see how well it can detect and measure tumors in patients with certain types of neuroendocrine tumors, particularly pheochromocytoma, paraganglioma, and neuroblastoma. The goal is to understand how effective this method is for diagnosing these tumors and assessing their size and spread in the body.

To participate in this trial, individuals must be at least one year old and have a confirmed or suspected diagnosis of a neural crest tumor. It’s important that they have already undergone a specific imaging test related to their condition within the last six months or are scheduled for it shortly after joining the study. Participants will need to sign a consent form to confirm they understand the study and agree to take part. If someone is pregnant, breastfeeding, or recently had surgery, they won't be eligible to join. Throughout the study, participants can expect to undergo the new imaging test and provide information that will help researchers learn more about these tumors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed. Patients with histologically confirmed or clinically suspicious neural crest tumor.
• • For patients with neuroblastoma, subject should have a routine clinical 123I-MIBG scintigraphy (planar + SPECT/CT) performed within 6 months prior to the inclusion visit or scheduled within 3 months after the inclusion visit.
• • The subject is male or is a nonpregnant, nonlactating female who is either surgically sterile or is post-menopausal. The subject is able and willing to comply with all study procedures as described in the protocol.
• Exclusion Criteria:
• • - Patients are potentially pregnant (serum and urinary hCG test will be performed in women where pregnancy is not excluded) or is breast-feeding.
• • Patients undergo surgery between the selection and inclusion visit. Patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating. Patients who are not suitable to participate in the trial according to researchers.