NCT03516747

Brief Summary

Identification and localization of pathological parathyroid gland before parathyroidectomy is traditionally done by a combination of two methods: ultrasound and sestamibi scan. The investigators would like to show that one exam that includes ultrasound and fine needle aspiration of the parathyroid gland for parathyroid hormone level is as accurate as the traditional method.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 9, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2020

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

April 3, 2018

Last Update Submit

April 3, 2022

Conditions

Parathyroid AdenomaHypercalcemia

Keywords

cytologyparathyroidectomyparathyroid hormone level

Outcome Measures

Primary Outcomes (2)

  • parathyroid hormone level from a pathological parathyroid gland

    Under ultrasound guidance, the investigators will locate a neck leison which based on previous localization imaging modalities, is proven to be a pathological parathyroid gland.The investigators will aspirate material from this gland and send it for measurement of parathyroid hormone level. we will prove that a lesion that contains high levels of parathyroid hormone is indeed a parathyroid gland. thereby, this method may replace other localization methods

    one month after the patient starts the study

  • parathyroid hormone level from a pathological parathyroid gland

    At surgical final step, after the pathological parathyroid gland is ex vivo the investigator will aspirate material from it and send it for measurement of parathyroid hormone level. we will prove that a lesion that contains high levels of parathyroid hormone is indeed a parathyroid gland.

    one month after the patient starts the study

Secondary Outcomes (2)

  • parathyroid gland cytology from a pathological parathyroid gland.

    one month after the patient starts the study

  • parathyroid gland cytology

    one month after the patient starts the study

Study Arms (1)

investigation group

EXPERIMENTAL

participants that suffer hypercalcemia due to primary hyperparathyroidism. include all participants in the trial

Diagnostic Test: pre operative parathyroid hormone level measurementDiagnostic Test: pre operative parathyroid cytologyDiagnostic Test: parathyroid hormone level measurementDiagnostic Test: parathyroid cytology

Interventions

pre operative parathyroid hormone level measurementDIAGNOSTIC_TEST

At the clinic, the participants will undergo ultrasound examination with fine needle aspiration. The aspirated material will be sent for parathyroid hormone level measurement.

investigation group
pre operative parathyroid cytologyDIAGNOSTIC_TEST

At the clinic, the participants will undergo neck ultrasound examination with fine needle aspiration. The aspirated material will be sent for cytology examination.

investigation group
parathyroid hormone level measurementDIAGNOSTIC_TEST

At surgery, after the pathologic gland is excised , the gland will be aspirated. The material will be sent for parathyroid hormone level measurement.

investigation group
parathyroid cytologyDIAGNOSTIC_TEST

At surgery, after the pathologic gland is excised , it will be aspirated again for cytologic examination.

investigation group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • above 18 years old
  • participants that suffer from primary hyperparathyroidism with an indication for parathyroidectomy

You may not qualify if:

  • Chronic renal failure
  • kidney transplant participant
  • MEN (multiple endocrine neoplasia) syndrome
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haemek Medical Center

Afula, 1834111, Israel

Location

MeSH Terms

Conditions

Parathyroid NeoplasmsHypercalcemia

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesParathyroid DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Study Officials

  • Dror Ashkenazi, M.D

    haemek medical center

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: open label, non- randomised, prospective
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.paker miki. principal investigator

Study Record Dates

First Submitted

April 3, 2018

First Posted

May 4, 2018

Study Start

June 9, 2018

Primary Completion

April 9, 2020

Study Completion

August 9, 2020

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

The investigators will not make individual participant data available due to the desire to preserve the privacy of the participants in the study

Locations

IL(1)