Actively Recruiting

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

A Study of 18F-MFBG Imaging for Tumor Burden and Diagnostic Performance in Pheochromocytoma, Paraganglioma, and Neuroblastoma

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

150

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the use of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) to evaluate neuroendocrine tumors, mainly pheochromocytoma, paraganglioma (PPGL), and neuroblastoma (NB). These tumors express norepinephrine transporter (NET), which is targeted by imaging substances like 123I/131I-MIBG. However, current imaging methods have limitations such as low resolution and long waiting times, which affect diagnosis. This study aims to assess the safety, image quality, diagnostic accuracy, and tumor burden detection of 18F-MFBG PET in these neural crest tumors.

CONDITIONS

Brief 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.
  • Patients have histologically confirmed or clinically suspected neural crest tumor.
  • Neuroblastoma patients should have routine 123I-MIBG scintigraphy (planar + SPECT/CT) within 6 months before or scheduled within 3 months after the inclusion visit.
  • Participants can be male or nonpregnant, nonlactating females who are surgically sterile or post-menopausal.
  • Participants must be able and willing to comply with all study procedures as described in the protocol.
Not Eligible

You will not qualify if you...

  • Patients who are potentially pregnant or breastfeeding.
  • Patients who undergo surgery between selection and inclusion visits.
  • Patients who are pregnant, may become pregnant, or wish to become pregnant during the study period.
  • Patients not suitable for trial participation according to researchers.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single day

Participants receive a single intravenous injection of 18F-MFBG followed by a PET/CT scan 60 minutes after injection. Some participants may also receive 68Ga-DOTATATE PET/CT scans for comparison. Neuroblastoma patients should have routine 123I-MIBG scintigraphy performed within 6 months before or within 3 months after this visit.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 2 years

Participants are observed to evaluate the diagnostic performance and lesion targeting of 18F-MFBG PET over an average of 1 to 2 years.

Follow-up visits as per clinical standard

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