PheochromocytomaNCT05948137
F-18 FDOPA PET/CT Versus I-123 MIBG Scintigraphy With SPECT/CT for the Diagnosis of Pheochromocytoma and Paraganglioma
An observational study of Pheochromocytoma and Paraganglioma, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Pheochromocytomas and paragangliomas (PPGLs) are chromaffin cells-derived tomours that originate from the adrenal medulla (80~85%) and the extra-adrenal sympathetic paraganglia in thorax, abdomen and pelvis (15~20%) or parasympathetic paraganglia in the head and neck region (~1%), respectively. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Pheochromocytoma, Paraganglioma
- What is being tested?
- F-18 FDOPA PET/CT
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Sep 2017to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suspected of having PPGL or those showing recurrence and/or distant metastasis of PPGL were enrolled
Who may be able to join
- suspected PPGL based on a biochemical screening, including 24-hour urinary total normetanephrine, metanephrine, norepinephrine, and epinephrine, along with plasma free concentrations of normetanephrine and metanephrine conducted within the past 6 months
- an adrenal incidentaloma, suggestive of PPGL on anatomical imaging (CT or MRI) performed within the past 6 months
- characteristic symptoms and signs of PPGL
- suspected of recurrence or metastases of known PPGL.
Who cannot join
- pregnant and lactating women
- individuals aged less than 15 years
- patients with a serum creatinine level greater than 3 mg/dL due to chronic renal failure
- patients with a second primary cancer that was not in complete remission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Comparative Study of 18F-FDOPA PET/CT Versus 123I-MIBG Scintigraphy With SPECT/CT for the Diagnosis of Pheochromocytoma and Paraganglioma
Pheochromocytomas and paragangliomas (PPGLs) are chromaffin cells-derived tomours that originate from the adrenal medulla (80~85%) and the extra-adrenal sympathetic paraganglia in thorax, abdomen and pelvis (15~20%) or parasympathetic paraganglia in the head and neck region (~1%), respectively. Functional imaging, such as 123I-Meta-Iodobenzylguanidine (MIBG) scintigraphy with single photon emission computed tomography with a CT (SPECT/CT), offers high specificity for PPGL but necessitates 24-hour delayed imaging, pre-processing thyroid protection with a potassium iodide solution, and medication reconciliation to prevent the inhibition of 123I-MIBG uptake. Conversely, 18F-L-dihydroxyphenylalanine (FDOPA), a radiopharmaceutical for positron emission tomography (PET) imaging, is specifically absorbed and accumulated by chromaffin cells, offering better image quality and convenience compared to 123I-MIBG scintigraphy. 18F-FDOPA PET/CT has been approved for the localization, staging, and detection of PPGL recurrences in European and other countries. Therefore, the aim of this study was to compare prospectively the diagnostic performances of 18F-FDOPA PET/CT and 123I-MIBG scintigraphy with SPECT/CT in patients with PPGL.
- Conditions
- Pheochromocytoma, Paraganglioma
- Being tested
- F-18 FDOPA PET/CT
- Medical subject headings
- Pheochromocytoma, Paraganglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 FDOPA PET/CTDiagnostic test
Also called I-123 MIBG SPECT/CT
Nuclear medicine imaging modalities
| Study group | Role | What they receive |
|---|---|---|
| Pheochromocytoma / paraganglioma | Not described Receives: Diagnostic Test: F-18 FDOPA PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority in diagnostic sensitivity of F-18 FDOPA PET/CT compared with that of I-123 MIBG SPECT/CT
Measured: Time interval of two imaging modalities was in the range of 1-15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start21 Sep 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: The study had to be prematurely stopped, falling short of the initial target due to prolonged shortages in the supply of 123I-MIBG.
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 Asan Medical CenterThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Sook Ryu, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948137
- Sponsor's protocol ID
- FDOPA_2014_0901
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study of 18F-FDOPA PET/CT Versus 123I-MIBG Scintigraphy With SPECT/CT for the Diagnosis of Pheochromocytoma and Paraganglioma
- ClinicalTrials.gov ID
- NCT05948137
- Acronym / sponsor ID
- FDOPA_2014_0901
- Conditions
- Pheochromocytoma, Paraganglioma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study had to be prematurely stopped, falling short of the initial target due to prolonged shortages in the supply of 123I-MIBG.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 17 Jul 2023 (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.
Pheochromocytomas and paragangliomas (PPGLs) are chromaffin cells-derived tomours that originate from the adrenal medulla (80~85%) and the extra-adrenal sympathetic paraganglia in thorax, abdomen and pelvis (15~20%) or parasympathetic paraganglia in the head and neck region (~1%), respectively. Functional imaging, such as 123I-Meta-Iodobenzylguanidine (MIBG) scintigraphy with single photon emission computed tomography with a CT (SPECT/CT), offers high specificity for PPGL but necessitates 24-hour delayed imaging, pre-processing thyroid protection with a potassium iodide solution, and medication reconciliation to prevent the inhibition of 123I-MIBG uptake. Conversely, 18F-L-dihydroxyphenylalanine (FDOPA), a radiopharmaceutical for positron emission tomography (PET) imaging, is specifically absorbed and accumulated by chromaffin cells, offering better image quality and convenience compared to 123I-MIBG scintigraphy. 18F-FDOPA PET/CT has been approved for the localization, staging, and detection of PPGL recurrences in European and other countries. Therefore, the aim of this study was to compare prospectively the diagnostic performances of 18F-FDOPA PET/CT and 123I-MIBG scintigraphy with SPECT/CT in patients with PPGL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pheochromocytoma / paraganglioma | – | Diagnostic Test: F-18 FDOPA PET/CT |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suspected of having PPGL or those showing recurrence and/or distant metastasis of PPGL were enrolled
Key inclusion criteria (4 listed)
- suspected PPGL based on a biochemical screening, including 24-hour urinary total normetanephrine, metanephrine, norepinephrine, and epinephrine, along with plasma free concentrations of normetanephrine and metanephrine conducted within the past 6 months
- an adrenal incidentaloma, suggestive of PPGL on anatomical imaging (CT or MRI) performed within the past 6 months
- characteristic symptoms and signs of PPGL
- suspected of recurrence or metastases of known PPGL.
Key exclusion criteria (4 listed)
- pregnant and lactating women
- individuals aged less than 15 years
- patients with a serum creatinine level greater than 3 mg/dL due to chronic renal failure
- patients with a second primary cancer that was not in complete remission
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 |
|---|---|---|
| F-18 FDOPA PET/CTAlso: I-123 MIBG SPECT/CTNuclear medicine imaging modalities | Diagnostic test | Pheochromocytoma / paraganglioma |
Primary outcome
Non-inferiority in diagnostic sensitivity of F-18 FDOPA PET/CT compared with that of I-123 MIBG SPECT/CT
Time frame: Time interval of two imaging modalities was in the range of 1-15 days
Results and safety
The study was stopped early (reason given: The study had to be prematurely stopped, falling short of the initial target due to prolonged shortages in the supply of 123I-MIBG.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pheochromocytoma and Paraganglioma, run by Asan Medical Center at 1 site in South Korea.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 17 Jul 2023. 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 South Korea. 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?
The study was stopped early (reason given: The study had to be prematurely stopped, falling short of the initial target due to prolonged shortages in the supply of 123I-MIBG.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority in diagnostic sensitivity of F-18 FDOPA PET/CT compared with that of I-123 MIBG SPECT/CT (time frame: Time interval of two imaging modalities was in the range of 1-15 days). 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 17 Jul 2023.