NCT00001394

Brief Summary

Occasionally tumors of the parathyroid gland cannot be detected by standard x-ray diagnostic procedures (CT scans, MRIs, and ultrasounds). In order for the tumor to be removed surgically it must first be localized. To do this often requires a procedure known as parathyroid arteriography and parathyroid venous sampling. This procedure begins by placing a catheter through a blood vessel in the groin. The catheter is then guided through blood vessels to reach the area of the neck. The blood vessels in this region flow in and out of the thyroid and parathyroid. An X-ray dye is then injected through the catheter into the arteries of the thyroid/parathyroid (parathyroid arteriography). The alternative is taking a small sample of the veins found in this same region (parathyroid venous sampling). Researchers prefer parathyroid arteriography because it causes less discomfort to the patient and requires less experience to do the procedure. However, parathyroid arteriography provides positive results in only 50% of patients undergoing the procedure. Parathyroid venous sampling provides greater amounts of positive results but the readings are often imprecise. Parathyroid tissue secretes a hormone known as PTH (parathyroid hormone). The release of PTH is stimulated by low levels of calcium in the blood. The idea behind the study is to inject a dye into the area of the parathyroid that will cause a release of PTH. Several parathyroid venous samplings will be taken following the abrupt elevation of PTH. This will provide information on the effectiveness of an intraarterial hypocalcemic stimulus (injection of dye into the arteries of the parathyroid when calcium blood levels are low) and venous sampling as techniques to improve localizing parathyroid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 1994

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 1994

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

July 1, 2005

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

HyperparathyroidismArterial StimulationVenous SamplingParathyroid AdenomaParathyroid Hyperplasia

Eligibility Criteria

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

You may qualify if:

  • Patients over the age of 2 who are enrolled in 91-DK-0085, "Studies of Hyperparathyroidism and Related Disorders", or patients who are undergoing parathyroid localization as part of routine patient care while enrolled in other Clinical protocols will be considered for the study.

You may not qualify if:

  • Patients will be excluded if:
  • There is any contraindication to arteriography.
  • The Patient is pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Parathyroid NeoplasmsHyperparathyroidism

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesParathyroid Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

August 1, 1994

Study Completion

July 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-07

Locations