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

NCT ID: NCT05948137

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-21
• Study Completion Date: 2020-06-30

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.

Conditions

Pheochromocytoma; Paraganglioma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pheochromocytoma / paraganglioma

F-18 FDOPA PET/CT

Intervention Type: DIAGNOSTIC_TEST

Nuclear medicine imaging modalities

Interventions

F-18 FDOPA PET/CT

Nuclear medicine imaging modalities

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

I-123 MIBG SPECT/CT

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jin-Sook Ryu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asan Medical Center

Seoul, Songpa-gu, South Korea

Countries

South Korea

Other Identifiers

FDOPA_2014_0901

Identifier Type: -

Identifier Source: org_study_id