NCT02381925

Brief Summary

The study aims are:

  1. 1.To compare the diagnostic performance of parathyroid four-dimensional CT (4D-CT), scintigraphy, and ultrasound in patients who underwent parathyroid surgery for primary hyperparathyroidism.
  2. 2.To compare 4D-CT, scintigraphy, and ultrasound for the ability to perform focused parathyroidectomy, and for rates of persistent hyperparathyroidism and complications from parathyroid surgery.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 21, 2015

Status Verified

September 1, 2015

First QC Date

March 3, 2015

Last Update Submit

September 17, 2015

Conditions

Keywords

CTScintigraphyUltrasound

Outcome Measures

Primary Outcomes (1)

  • diagnostic performance of imaging

    6 months

Secondary Outcomes (3)

  • ability to perform focused parathyroidectomy

    6 months

  • rates of persistent hyperparathyroidism after parathyroidectomy

    6 months

  • parathyroidectomy surgical complications

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The subjects will include all patients, aged 18 years or older, who underwent parathyroid surgery from July 2009 to July 2016.

You may qualify if:

  • patients having parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016

You may not qualify if:

  • age less than 18 years
  • parathyroid carcinoma
  • secondary or tertiary hyperparathyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parathyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesParathyroid Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 6, 2015

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

September 21, 2015

Record last verified: 2015-09