The Utility of 18F-fluorocholine PET/CT in the Imaging of Parathyroid Adenomas

Hyperparathyroidism Clinical Trial

Official title:

The Utility of 18F-fluorocholine PET/CT in the Imaging of Parathyroid Adenomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04570033
• Other study ID #: Military Institute of Medicine
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: January 1, 2020

Study information

• Verified date: September 2020
• Source: Military Institute of Medicine, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism (PHPT).

Description:

We prospectively enrolled 65 consecutive patients with PHPT who underwent neck ultrasound (US) and parathyroid scintigraphy (99mTc/99mTc-MIBI dual phase). Twenty-two patients had unsuccessful parathyroid surgery prior to the study. PET/CT scans were performed 65.0 ± 13.3 min after injection of 218.5 ± 31.9 MBq of 18F-fluorocholine (FCH). Three experienced nuclear medicine physicians assessed the detection rate of hyperfunctioning parathyroid tissue. Response to parathyroidectomy and clinical follow-up served as a reference test. Per-patient sensitivity and positive predictive value (PPV) were calculated for patients who underwent surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• primary hyperparathyroidism and neck US and the dual-phase 99mTc/99mTc-MIBI SPECT/CT scintigraphy performed prior to the PET/CT scan

Exclusion Criteria:

• pregnancy

• patient's lack of consent to the examination

Related Conditions & MeSH terms

• Adenoma
• Hyperparathyroidism
• Parathyroid Adenoma
• Parathyroid Neoplasms

Intervention

Diagnostic Test:
• We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism
We prospectively enrolled 65 consecutive patients with PHPT who underwent neck ultrasound (US) and parathyroid scintigraphy (99mTc/99mTc-MIBI dual phase). Twenty-two patients had unsuccessful parathyroid surgery prior to the study. PET/CT scans were performed 65.0 ± 13.3 min after injection of 218.5 ± 31.9 MBq of 18F-fluorocholine (FCH). Three experienced nuclear medicine physicians assessed the detection rate of hyperfunctioning parathyroid tissue. Response to parathyroidectomy and clinical follow-up served as a reference test. Per-patient sensitivity and positive predictive value (PPV) were calculated for patients who underwent surgery.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Military Institute of Medicine, Poland	Medical University of Warsaw

References & Publications (3)

Cordellat IM. Hyperparathyroidism: primary or secondary disease? Reumatol Clin. 2012 Sep-Oct;8(5):287-91. Epub 2011 Oct 20. Review. — View Citation

López-Mora DA, Sizova M, Estorch M, Flotats A, Camacho V, Fernández A, Abouzian S, Fuentes-Ocampo F, Garcia JIP, Ballesteros AIC, Duch J, Domènech A, Duarte AM, Carrió I. Superior performance of 18F-fluorocholine digital PET/CT in the detection of parathy — View Citation

Wilhelm SM, Wang TS, Ruan DT, Lee JA, Asa SL, Duh QY, Doherty GM, Herrera MF, Pasieka JL, Perrier ND, Silverberg SJ, Solórzano CC, Sturgeon C, Tublin ME, Udelsman R, Carty SE. The American Association of Endocrine Surgeons Guidelines for Definitive Manage — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The utility of 18F-fluorocholine PET/CT in the imaging of parathyroid adenomas	Sensitivity and positive predictive value of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism	24 months