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

Last updated: July 13, 2023
Sponsor: Asan Medical Center
Overall Status: Terminated

Phase

N/A

Condition

Neuroendocrine Carcinoma

Treatment

F-18 FDOPA PET/CT

Clinical Study ID

NCT05948137
FDOPA_2014_0901
  • Ages 15-80
  • All Genders

Study Summary

Pheochromocytomas and paragangliomas (PPGLs) are chromaffin cells-derived tomours that originate from the adrenal medulla (8085%) and the extra-adrenal sympathetic paraganglia in thorax, abdomen and pelvis (1520%) 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

Inclusion Criteria:

  1. suspected PPGL based on a biochemical screening, including 24-hour urinary totalnormetanephrine, metanephrine, norepinephrine, and epinephrine, along with plasma freeconcentrations 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

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 renalfailure
  • patients with a second primary cancer that was not in complete remission

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: F-18 FDOPA PET/CT
Phase:
Study Start date:
September 21, 2017
Estimated Completion Date:
June 30, 2020

Connect with a study center

  • Asan Medical Center

    Seoul, Songpa-gu 05505
    Korea, Republic of

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.