NCT04570033

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

4 years

First QC Date

September 21, 2020

Last Update Submit

September 25, 2020

Conditions

HyperparathyroidismParathyroid Adenoma

Keywords

PET/CTfluorocholine

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

patients with hyperparathyroidism

EXPERIMENTAL

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

Interventions

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

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.

patients with hyperparathyroidism

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnancy
  • patient's lack of consent to the examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Cordellat IM. Hyperparathyroidism: primary or secondary disease? Reumatol Clin. 2012 Sep-Oct;8(5):287-91. doi: 10.1016/j.reuma.2011.06.001. Epub 2011 Oct 20.

    PMID: 22089066RESULT

  • Wilhelm SM, Wang TS, Ruan DT, Lee JA, Asa SL, Duh QY, Doherty GM, Herrera MF, Pasieka JL, Perrier ND, Silverberg SJ, Solorzano CC, Sturgeon C, Tublin ME, Udelsman R, Carty SE. The American Association of Endocrine Surgeons Guidelines for Definitive Management of Primary Hyperparathyroidism. JAMA Surg. 2016 Oct 1;151(10):959-968. doi: 10.1001/jamasurg.2016.2310.

    PMID: 27532368RESULT

  • Lopez-Mora DA, Sizova M, Estorch M, Flotats A, Camacho V, Fernandez A, Abouzian S, Fuentes-Ocampo F, Garcia JIP, Ballesteros AIC, Duch J, Domenech A, Duarte AM, Carrio I. Superior performance of 18F-fluorocholine digital PET/CT in the detection of parathyroid adenomas. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):572-578. doi: 10.1007/s00259-020-04680-7. Epub 2020 Jan 9.

    PMID: 31919634RESULT

MeSH Terms

Conditions

HyperparathyroidismParathyroid Neoplasms

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck Neoplasms

Study Officials

  • Andrzej Mazurek, MD, PhD

    Military Institute of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 30, 2020

Study Start

January 1, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

September 30, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share