PheochromocytomaNCT06813742
18F-mFBG PET Imaging in the Evaluation of Pheochromocytoma
An observational study of Pheochromocytoma, run by First Affiliated Hospital of Zhejiang University at 2 sites 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 pheochromocytoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pheochromocytoma
- What is being tested?
- 18F-MFBG
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2023to Dec 2026
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with suspected or confirmed pheochromocytoma
Who may be able to join
- Aged 30-80 years old, primary school or above, with a regular caregiver;
- Clinically diagnosed patients with pheochromocytoma;
- Can provide informed consent, can understand and comply with the study requirements.
Who cannot join
- Patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system;
- Uncontrolled hypertension or high-risk BP (i.e., systolic BP > 180 mmHg or diastolic BP > 110 mmHg);
- Patients with mental disorders or primary affective disorders;
- Unable to understand and adhere to the study protocol or provide informed consent;
- Contraindications to PET imaging (including pregnant women, lactating women, and women of childbearing age with recent childbearing plans, etc.);
- Allergy to imaging agents;
- Patients who were unable to cooperate with PET scanning, such as hypoglycemia, severe pain or tremor.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Xinhui Su, MD, 86 13806071262, suxinhui@zju.edu.cn
- Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
Peipei Wang, MD, 86 18511395988, wpp199411@163.com
Xinhui Su, MD, 86 13806071262, suxinhui@zju.edu.cn
About this study
Official title: A Prospective Exploratory Study Evaluating the Diagnostic Usefulness of 18F-mFBG PET Imaging in Pheochromocytoma
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 pheochromocytoma.
Read the detailed description
Pheochromocytoma highly expresses norepinephrine transporter (NET) which is targeted by function alanalogue of norepinephrine, 123/131I-MlBG. However, low spatial resolution of 123/131I-MlBG and inaccurate attenuation correction of single photon emission tomography (SPECT/CT) will affect the image quality of MlBG SPECT and lead to poor diagnosis of small lesions. In addition, 123l-MlBG imaging is usually performed at 24h after injection, while 131I-MlBG is performed at 48h or even 72h 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. Patients with suspected or histologically confirmed pheochromocytoma will be enrolled in this study.
- Conditions
- Pheochromocytoma
- Being tested
- 18F-MFBG
- Medical subject headings
- Pheochromocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-MFBGDrug
Patients with pheochromocytoma malignancies receive 5.55 MBq/kg of 18F-MFBG intravenously followed by PET/CT or PET/MR after 60min of injection.
| Study group | Role | What they receive |
|---|---|---|
| 18F-MFBG PET/CT in Pheochromocytoma | Each patient receive a single intravenous injection of 18F-MFBG 5.55 MBq/kg and undergo PET/CT or PET/MR scan after 60 min post-injection. Receives: Drug: 18F-MFBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between positive and negative 18F-mFBG PET/CT or PET/MR Imaging and pathological diagnosis and treatment effect in patients with pheochromocytoma.
Main outcome measure
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
False positive and false negative results of 18F-mFBG PET/CT or PET/MR Imaging in patients with pheochromocytoma.
Secondary outcome measure
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 May 2023
- Primary completion5 Dec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813742
- Sponsor's protocol ID
- FAHZU-MFBG-PHEO
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Exploratory Study Evaluating the Diagnostic Usefulness of 18F-mFBG PET Imaging in Pheochromocytoma
- ClinicalTrials.gov ID
- NCT06813742
- Acronym / sponsor ID
- FAHZU-MFBG-PHEO
- Conditions
- Pheochromocytoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 5 Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Feb 2025 (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 pheochromocytoma.
Detailed description
Pheochromocytoma highly expresses norepinephrine transporter (NET) which is targeted by function alanalogue of norepinephrine, 123/131I-MlBG. However, low spatial resolution of 123/131I-MlBG and inaccurate attenuation correction of single photon emission tomography (SPECT/CT) will affect the image quality of MlBG SPECT and lead to poor diagnosis of small lesions. In addition, 123l-MlBG imaging is usually performed at 24h after injection, while 131I-MlBG is performed at 48h or even 72h 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. Patients with suspected or histologically confirmed pheochromocytoma will be enrolled in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-MFBG PET/CT in Pheochromocytoma | – | Drug: 18F-MFBGEach patient receive a single intravenous injection of 18F-MFBG 5.55 MBq/kg and undergo PET/CT or PET/MR scan after 60 min post-injection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with suspected or confirmed pheochromocytoma
Key inclusion criteria (3 listed)
- Aged 30-80 years old, primary school or above, with a regular caregiver;
- Clinically diagnosed patients with pheochromocytoma;
- Can provide informed consent, can understand and comply with the study requirements.
Key exclusion criteria (7 listed)
- Patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system;
- Uncontrolled hypertension or high-risk BP (i.e., systolic BP > 180 mmHg or diastolic BP > 110 mmHg);
- Patients with mental disorders or primary affective disorders;
- Unable to understand and adhere to the study protocol or provide informed consent;
- Contraindications to PET imaging (including pregnant women, lactating women, and women of childbearing age with recent childbearing plans, etc.);
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-MFBGPatients with pheochromocytoma malignancies receive 5.55 MBq/kg of 18F-MFBG intravenously followed by PET/CT or PET/MR after 60min of injection. | Drug | 18F-MFBG PET/CT in Pheochromocytoma |
Primary outcome
Correlation between positive and negative 18F-mFBG PET/CT or PET/MR Imaging and pathological diagnosis and treatment effect in patients with pheochromocytoma.
Time frame: through study completion, an average of 1 year
Main outcome measure
1 secondary outcome
False positive and false negative results of 18F-mFBG PET/CT or PET/MR Imaging in patients with pheochromocytoma.
Time frame: through study completion, an average of 1 year
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 7 Aug 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pheochromocytoma, run by First Affiliated Hospital of Zhejiang University at 2 sites 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 7 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 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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, MD (86 18511395988, wpp199411@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between positive and negative 18F-mFBG PET/CT or PET/MR Imaging and pathological diagnosis and treatment effect in patients with pheochromocytoma. (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?
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 7 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.