NCT03203668

Brief Summary

To assess the efficiency of 18F-fluorocholine PET/CT in localization of hyperfunctioning parathyroid tissue in hyperparathyroidism, thereby enabling minimally invasive surgical approaches with fewer complications and comparable success rates

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2013

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

8 years

First QC Date

April 17, 2017

Last Update Submit

June 30, 2017

Conditions

Hyperparathyroidism

Keywords

HyperparathyroidismImagingScintigraphy18F-choline18F-fluorocholinePETPET/CT

Outcome Measures

Primary Outcomes (1)

  • Sensitivity & Specificity

    Ability to detect the hyperfunctioning parathyroid tissue

    3 months

Secondary Outcomes (6)

  • Biochemical/clinical outcome - iPTH levels

    1 year

  • Biochemical/clinical outcome - Ca2+ levels

    1 year

  • Improvement in patient management - operating time

    3 years

  • Improvement in patient management - duration of hospital stay

    3 years

  • Improvement in patient management - complications of surgery

    3 years

  • +1 more secondary outcomes

Study Arms (1)

Choline PET/CT

OTHER

Choline PET/CT imaging added to conventional imaging assessment in hyperparathyroidism (parathyroid scintigraphy, ultrasound, CT or MRI if indicated)

Radiation: 18F-choline PET/CT

Interventions

18F-choline PET/CTRADIATION

18F-choline PET/CT imaging (neck, mediastinum)

Choline PET/CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years
  • Biochemically proven hyperparathyroidism (elevated iPTH, elevated on normal Ca2+) or elevated Ca2+ and inadequately supressed iPTH

You may not qualify if:

  • Age under 18 years
  • Pregnancy
  • Clinical history of oncological, inflammatory/infectious disease of the head and neck

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for nuclear medicine, University medical centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (3)

  • Lezaic L, Rep S, Sever MJ, Kocjan T, Hocevar M, Fettich J. (1)(8)F-Fluorocholine PET/CT for localization of hyperfunctioning parathyroid tissue in primary hyperparathyroidism: a pilot study. Eur J Nucl Med Mol Imaging. 2014 Nov;41(11):2083-9. doi: 10.1007/s00259-014-2837-0. Epub 2014 Jul 26.

    PMID: 25063039RESULT

  • Rep S, Lezaic L, Kocjan T, Pfeifer M, Sever MJ, Simoncic U, Tomse P, Hocevar M. Optimal scan time for evaluation of parathyroid adenoma with [(18)F]-fluorocholine PET/CT. Radiol Oncol. 2015 Nov 27;49(4):327-33. doi: 10.1515/raon-2015-0016. eCollection 2015 Dec.

    PMID: 26834518RESULT

  • Hocevar M, Lezaic L, Rep S, Zaletel K, Kocjan T, Sever MJ, Zgajnar J, Peric B. Focused parathyroidectomy without intraoperative parathormone testing is safe after pre-operative localization with 18F-Fluorocholine PET/CT. Eur J Surg Oncol. 2017 Jan;43(1):133-137. doi: 10.1016/j.ejso.2016.09.016. Epub 2016 Oct 21.

    PMID: 27776943RESULT

MeSH Terms

Conditions

Hyperparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Central Study Contacts

Luka Lezaic, MD PhD

CONTACT

+386 1 522 84 50luka.lezaic@kclj.si

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

April 17, 2017

First Posted

June 29, 2017

Study Start

January 1, 2013

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)