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

Sponsor

Military Institute of Medicine, Poland (Other)

Overall Status

Completed

CT.gov ID

NCT04570033

Collaborator

Medical University of Warsaw (Other)

Enrollment

Arm

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hyperparathyroidism Parathyroid Adenoma	Diagnostic Test: We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patients with hyperparathyroidism We prospectively enrolled 65 consecutive patients with primary hyperparathyroidism (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	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.

Arm

Intervention/Treatment

Experimental: patients with hyperparathyroidism

We prospectively enrolled 65 consecutive patients with primary hyperparathyroidism (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

Diagnostic Test: We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism

Outcome Measures

Primary Outcome Measures

The utility of 18F-fluorocholine PET/CT in the imaging of parathyroid adenomas [24 months]
Sensitivity and positive predictive value of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Military Institute of Medicine, Poland
Medical University of Warsaw

Investigators

Principal Investigator: Andrzej Mazurek, MD, PhD, Military Institute of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrzej Mazurek, MD PhD, Military Institute of Medicine, Poland

ClinicalTrials.gov Identifier:

NCT04570033

Other Study ID Numbers:

Military Institute of Medicine

First Posted:

Sep 30, 2020

Last Update Posted:

Sep 30, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Andrzej Mazurek, MD PhD, Military Institute of Medicine, Poland

PET/CT

fluorocholine

Additional relevant MeSH terms:

Adenoma

Parathyroid Neoplasms

Hyperparathyroidism

Parathyroid Hormone

Study Results

No Results Posted as of Sep 30, 2020