Neuroendocrine TumorEarly Phase 1NCT05069220
18F-MFBG PET/CT in the Evaluation of Neural Crest Tumor
A Early Phase 1 study testing 18F-MFBG and 68Ga-Dotatate in people with Neuroendocrine Tumor and Neuroblastoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Neuroendocrine Tumor, Neuroblastoma, Pheochromocytoma
- What is being tested?
- 18F-MFBG and 68Ga-Dotatate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking union medical college hospital
Beijing, Dongcheng, 100010
Peipei Wang, 18511395988, wpp199411@163.com
About this study
Official title: A Study of 18F-MFBG Imaging for the Tumor Burden Evaluation or Diagnostic Performance in Pheochromocytoma, Paraganglioma and Neuroblastoma.
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).
Read the detailed description
Pheochromocytoma and paraganglioma (PPGL) and neuroblastoma (NB) highly express norepinephrine transporter (NET) which is targeted by functional analogue of norepinephrine, 131I/123I-MIBG. However, low spatial resolution of 123/131I-MIBG and inaccurate attenuation correction of single photon emission tomography (SPECT/CT) will affect the image quality of MIBG SPECT and lead to poor diagnosis of small lesions. In addition, 123I-MIBG imaging is usually performed at 24 h after injection, while 131I-MIBG is performed at 48 h or even 72 h after injection. The procedure is complicated and takes a long time, which limits clinical application. 18F-labeled MFBG is an ideal tracer to show the expression of NET. Preliminary data show that 18F-MFBG imaging is safe and has favorable biodistribution and kinetics with good targeting of lesions. Patients can undergo PET 0.5 hours after injection without special preparation. Our study will assess the safety profile, image quality and evaluate the diagnostic performance and tumor burden of 18F-MFBG on nural crest tumors including PPGL and NB. Patients with histologically confirmed or clinically suspected neural crest tumor will be prospectively recruited in this study.
- Conditions
- Neuroendocrine Tumor, Neuroblastoma, Pheochromocytoma, Paraganglioma
- Being tested
- 18F-MFBG, 68Ga-Dotatate
- Medical subject headings
- Neuroendocrine Tumors, Neuroblastoma, Pheochromocytoma, Paraganglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-MFBGDrug
Also called 18F-metafluorobenzylguanidine
Patients with neuroendocrine malignancies receive 2-4 MBq/kg of 18F-MFBG intravenously followed by PET/CT after 60min of injection.
68Ga-DotatateDrug
Patients with malignant PPGL and NB receive intravenously 68Ga-Dotatate followed by PET/CT after 40min of injection.
| Study group | Role | What they receive |
|---|---|---|
| 18F-MFBG PET/CT in neuroendocrine malignancies | Experimental | 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. Receives: Drug: 18F-MFBG; Drug: 68Ga-Dotatate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of diagnostic performance of 18F-MFBG PET in different regions in metastatic neural crest tumor.
Patients with histologically confirmed metastatic neural crest tumor will be prospectively recruited in this study. They will receive 18F-MFBG PETand 123I-MIBG SPECT. Rate of detected lesions (visual) in bone, lymph node and liver will be compared.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Assessment of lesion targeting by 18F-MFBG as compared to 68Ga-DOTATATE
A lesion-by-lesion analysis will be performed to compare the number of detected lesions using 18F-MFBG and 68Ga-DOTATATE.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Sep 2021
- Primary completionSep 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fang Li, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069220
- Sponsor's protocol ID
- ZS-3060MFBG
- Status last verified
- Feb 2024
- First submitted
- 20 Sep 2021
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang P, Yu S, Chen X, Zheng X, Mao J, Jing H, Zhuang H, Li F, Su X. [18F]MFBG PET/CT is an effective and preferable imaging modality for neuroblastoma in a prospective comparison with SSTR PET. Eur J Nucl Med Mol Imaging. 2026 Jan;53(2):899-909. doi: 10.1007/s00259-025-07449-y. Epub 2025 Jul 28.
PubMed 40717185Wang P, Li T, Liu Z, Jin M, Su Y, Zhang J, Jing H, Zhuang H, Li F. [18F]MFBG PET/CT outperforming [123I]MIBG SPECT/CT in the evaluation of neuroblastoma. Eur J Nucl Med Mol Imaging. 2023 Aug;50(10):3097-3106. doi: 10.1007/s00259-023-06221-4. Epub 2023 May 9.
PubMed 37160439
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of 18F-MFBG Imaging for the Tumor Burden Evaluation or Diagnostic Performance in Pheochromocytoma, Paraganglioma and Neuroblastoma.
- ClinicalTrials.gov ID
- NCT05069220
- Acronym / sponsor ID
- ZS-3060MFBG
- Conditions
- Neuroendocrine Tumor, Neuroblastoma, Pheochromocytoma, Paraganglioma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Pheochromocytoma and paraganglioma (PPGL) and neuroblastoma (NB) highly express norepinephrine transporter (NET) which is targeted by functional analogue of norepinephrine, 131I/123I-MIBG. However, low spatial resolution of 123/131I-MIBG and inaccurate attenuation correction of single photon emission tomography (SPECT/CT) will affect the image quality of MIBG SPECT and lead to poor diagnosis of small lesions. In addition, 123I-MIBG imaging is usually performed at 24 h after injection, while 131I-MIBG is performed at 48 h or even 72 h after injection. The procedure is complicated and takes a long time, which limits clinical application. 18F-labeled MFBG is an ideal tracer to show the expression of NET. Preliminary data show that 18F-MFBG imaging is safe and has favorable biodistribution and kinetics with good targeting of lesions. Patients can undergo PET 0.5 hours after injection without special preparation. Our study will assess the safety profile, image quality and evaluate the diagnostic performance and tumor burden of 18F-MFBG on nural crest tumors including PPGL and NB. Patients with histologically confirmed or clinically suspected neural crest tumor will be prospectively recruited in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-MFBG PET/CT in neuroendocrine malignancies | Experimental | Drug: 18F-MFBG, Drug: 68Ga-DotatateEach 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. |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-MFBGAlso: 18F-metafluorobenzylguanidinePatients with neuroendocrine malignancies receive 2-4 MBq/kg of 18F-MFBG intravenously followed by PET/CT after 60min of injection. | Drug | 18F-MFBG PET/CT in neuroendocrine malignancies |
| 68Ga-DotatatePatients with malignant PPGL and NB receive intravenously 68Ga-Dotatate followed by PET/CT after 40min of injection. | Drug | 18F-MFBG PET/CT in neuroendocrine malignancies |
Primary outcome
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
Patients with histologically confirmed metastatic neural crest tumor will be prospectively recruited in this study. They will receive 18F-MFBG PETand 123I-MIBG SPECT. Rate of detected lesions (visual) in bone, lymph node and liver will be compared.
1 secondary outcome
Assessment of lesion targeting by 18F-MFBG as compared to 68Ga-DOTATATE
Time frame: through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Derived from this study: PubMed 40717185Wang P, Yu S, Chen X, Zheng X, Mao J, Jing H, Zhuang H, Li F, Su X. [18F]MFBG PET/CT is an effective and preferable imaging modality for neuroblastoma in a prospective comparison with SSTR PET. Eur J Nucl Med Mol Imaging. 2026 Jan;53(2):899-909. doi: 10.1007/s00259-025-07449-y. Epub 2025 Jul 28.
- Derived from this study: PubMed 37160439Wang P, Li T, Liu Z, Jin M, Su Y, Zhang J, Jing H, Zhuang H, Li F. [18F]MFBG PET/CT outperforming [123I]MIBG SPECT/CT in the evaluation of neuroblastoma. Eur J Nucl Med Mol Imaging. 2023 Aug;50(10):3097-3106. doi: 10.1007/s00259-023-06221-4. Epub 2023 May 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fang Li principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-MFBG and 68Ga-Dotatate in people with Neuroendocrine Tumor and Neuroblastoma, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peipei Wang (18511395988, wpp199411@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05069220, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024; AzTrials last refreshed its copy on 26 Oct 2026.