Clinical trial NCT05948137: F-18 FDOPA PET/CT Versus I-123 MIBG Scintigraphy With SPECT/CT for the Diagnosis of Pheochromocytoma and Paraganglioma
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pheochromocytoma
Paraganglioma
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 32
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suspected of having PPGL or those showing recurrence and/or distant metastasis of PPGL were enrolled

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. an adrenal incidentaloma, suggestive of PPGL on anatomical imaging (CT or MRI) performed within the past 6 months
3. characteristic symptoms and signs of PPGL
4. suspected of recurrence or metastases of known PPGL.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Non-inferiority in diagnostic sensitivity of F-18 FDOPA PET/CT compared with that of I-123 MIBG SPECT/CT
timeFrame: Time interval of two imaging modalities was in the range of 1-15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
References: