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

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05069220
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 18F-MFBG — DRUG
    Patients with neuroendocrine malignancies receive 2-4 MBq/kg of 18F-MFBG intravenously followed by PET/CT after 60min of injection.
  • 68Ga-Dotatate — DRUG
    Patients with malignant PPGL and NB receive intravenously 68Ga-Dotatate followed by PET/CT after 40min of injection.

Study Details

The aim of this study is to evaluate the diagnostic performance and tumor burden of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients with neuroendocrine tumors mainly in pheochromocytoma and paraganglioma (PPGL) and neuroblastoma (NB).

Key Dates

First listed
Oct 6, 2021
Start date
Sep 1, 2021
Status verified
Feb 2024
Primary completion
Sep 30, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 18F-MFBG PET/CT in neuroendocrine malignancies
    Each patient receive a single intravenous injection of 18F-MFBG 2-4 MBq/kg and undergo PET/CT scan after 60 min post-injection. Patients with neuroblastoma should have a routine clinical 123I-MIBG scintigraphy (planar and/or SPECT/CT) performed within 6 months prior to the inclusion visit or scheduled within 3 months after the inclusion visit. According to patients' condition and clinical management, part of patients with PPGL and NB will receive 68Ga-DOTATATE PET/CT, comparing with 18F-MFBG PET/CT.

Primary Outcome Measure

The evaluation of diagnostic performance of 18F-MFBG PET in different regions in metastatic neural crest tumor. [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Find similar trials

Nationwide
Neuroblastoma trialsNeuroendocrine tumors trialsOncology trialsPediatric oncology trials

Related Studies