Actively Recruiting

Early Phase 1
Age: 1Year - 80Years
All Genders
ID05069220

18F-MFBG PET/CT Imaging to Evaluate Tumor Burden and Diagnosis in Pheochromocytoma, Paraganglioma, and Neuroblastoma

Led by Peking Union Medical College Hospital · Updated on 2024-03-01

150

Participants Needed

1

Research Sites

273 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) to assess tumor burden and diagnostic accuracy in patients with neuroendocrine tumors, mainly pheochromocytoma, paraganglioma (PPGL), and neuroblastoma (NB). These tumors express norepinephrine transporter (NET), which is targeted by traditional imaging agents like 131I/123I-MIBG. However, current imaging methods have limitations such as low resolution, long procedure times, and poor detection of small lesions. This study aims to explore the safety, image quality, and diagnostic potential of 18F-MFBG PET in these conditions. Participants will receive an intravenous injection of 18F-MFBG at a dose of 2-4 MBq/kg, followed by PET/CT scanning 60 minutes post-injection. Patients with malignant PPGL and NB may also receive 68Ga-Dotatate intravenously, with PET/CT conducted 40 minutes after injection. The short imaging time and favorable characteristics of 18F-MFBG could improve detection and evaluation of neural crest tumors. The study will include patients with confirmed or suspected neural crest tumors, including PPGL and NB. During the study, participants will undergo safety assessments and imaging procedures to evaluate tumor presence and extent. Diagnostic performance of 18F-MFBG PET will be measured across different tumor regions over approximately one year. Patients with neuroblastoma are expected to have routine 123I-MIBG scintigraphy within six months before or three months after enrollment. The study will monitor imaging quality, tumor burden, and safety throughout the participation period.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Year - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The participant has read, signed, and dated an informed consent form before any study procedures.
  • Patient has histologically confirmed or clinically suspected neural crest tumor.
  • Neuroblastoma patients should have 123I-MIBG scintigraphy within 6 months before or scheduled within 3 months after inclusion.
  • Participant is male or a nonpregnant, nonlactating female who is surgically sterile or post-menopausal.
  • Participant is able and willing to comply with all study procedures as described.
Not Eligible

You will not qualify if you...

  • Patients who are pregnant, possibly pregnant, or breastfeeding.
  • Patients undergoing surgery between selection and inclusion visits.
  • Patients who may become pregnant or wish to become pregnant during the study period (including their partners).
  • Patients deemed unsuitable by researchers to participate in the trial.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking union medical college hospital

Beijing, Dongcheng, China, 100010

Actively Recruiting

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Research Team

P

Peipei Wang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

[18F]MFBG PET/CT is an effective and preferable imaging modality for neuroblastoma in a prospective comparison with SSTR PET.

Peipei Wang, Sun Yu, Xiaorui Chen...

https://pubmed.ncbi.nlm.nih.gov/40717185