F-18 FDOPA PET/CT Versus I-123 MIBG Scintigraphy With SPECT/CT for the Diagnosis of Pheochromocytoma and Paraganglioma

Asan Medical Center

Status: Terminated

Conditions: Paraganglioma; Pheochromocytoma

Treatments: Diagnostic Test: F-18 FDOPA PET/CT

Study type: Observational

Funder types: Other

Identifiers

NCT05948137

FDOPA_2014_0901

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

32 participants in 1 patient group

Pheochromocytoma / paraganglioma

Treatment:

Diagnostic Test: F-18 FDOPA PET/CT