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

NCT05948137 | Terminated

• 1 other identifier: FDOPA_2014_0901
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Non-inferiority in diagnostic sensitivity of F-18 FDOPA PET/CT compared with that of I-123 MIBG SPECT/CT

  Time interval of two imaging modalities was in the range of 1-15 days

Study Arms (1)

Pheochromocytoma / paraganglioma

Diagnostic Test: F-18 FDOPA PET/CT

Interventions

F-18 FDOPA PET/CT DIAGNOSTIC_TEST

Nuclear medicine imaging modalities

Also known as: I-123 MIBG SPECT/CT

Pheochromocytoma / paraganglioma

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suspected of having PPGL or those showing recurrence and/or distant metastasis of PPGL were enrolled

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

MeSH Terms

Conditions

Pheochromocytoma; Paraganglioma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 17, 2023
• Study Start: September 21, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)