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Minimally Invasive Radioguided Parathyroidectomy (MIRP)

This study is currently recruiting participants.
Verified February 2012 by University of Louisville
Sponsor:
Collaborators:
Norton Healthcare
Jewish Hospital and St. Mary's Healthcare
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT01530919
First received: November 30, 2011
Last updated: April 4, 2012
Last verified: February 2012
History of Changes
  Purpose

The main purpose of this research study is to evaluate the effectiveness of a minimally invasive surgical approach to removing parathyroid gland(s). The researchers are also interested in analyzing abnormal parathyroid tissue for changes in genes and proteins that may contribute to overactive parathyroid gland(s).


Condition Intervention
Primary Hyperparathyroidism
 Other: Minimally invasive radioguided parathyroidectomy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Minimally Invasive Radioguided Parathyroidectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • The positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas. [ Time Frame: 2-3days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The value of intraoperative parathyroid hormone assay to verify biochemical cure or primary hyperparathyroidism [ Time Frame: 2-3 days ] [ Designated as safety issue: No ]
  • Collection of abnormal parathyroid tissue at the time of surgery for tissue analysis [ Time Frame: day of surgery (1 day) ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: September 1998
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Minimally invasive radioguided parathyroidectomy
    After the patient is prepared for surgery and under local anesthesia, the initial incision by the surgeon will be 2-3 cm. The surgeon will dissect in the designated quadrant until the parathyroid gland is identified.
Detailed Description:

The specific aims of this study are to determine the safety and efficacy of minimally invasive radioguided parathyroidectomy, to determine the positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas, and to differentiate adenomas from parathyroid hyperplasia. In addition, this study aims to determine the value of intraoperative parathyroid hormone assay to verify biochemical cure of primary hyperparathyroidism, to determine whether minimally invasive radioguided parathyroidectomy is cos-effective, and to collect abnormal parathyroid tissue at the time of surgery for tissue analysis.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with biochemical evidence of primary hyperparathyroidism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530919

Locations
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Michael B Flynn, M.D.     502-629-3355     mbflyn01@louisville.edu    
Principal Investigator: Michael J. Flynn, M.D.            
Sponsors and Collaborators
University of Louisville
Norton Healthcare
Jewish Hospital and St. Mary's Healthcare
Investigators
Principal Investigator: Michael J Flynn, M.D. University of Louisville
  More Information

No publications provided

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01530919     History of Changes
Other Study ID Numbers: 291.97
Study First Received: November 30, 2011
Last Updated: April 4, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013