Evaluation of MRI and SPECT Fusion Software to Localize Parathyroid Adenomas

This study has been terminated.
(Subject population not available.)
Sponsor:
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00639405
First received: March 12, 2008
Last updated: April 26, 2011
Last verified: October 2008
  Purpose

The purpose of this study is to design a method to better localize parathyroid adenomas. This study will include approximately 6 patients who have not had surgery and another 25 patients who have already had surgery over the course of one year.


Condition
Parathyroid Neoplasm
Parathyroid Diseases

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Localization of Parathyroid Adenomas Using MRI and SPECT Fusion Software in Patients With Persistent or Recurrent Hyperparathyroidism

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Enrollment: 12
Study Start Date: September 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
subjects who are diagnosed with parathyroid adenomas. There will be 6 subjects who have not had surgery and 25 subjects who have had surgery.

Detailed Description:

While a successful neck exploration for PHP is primarily dependent on the experience of the surgeon, there are currently several localizing studies available to increase success. Although the necessity of localizing studies pre-operatively for first time neck explorations is still under debate, there is no question of their importance for persistent or recurrent PHP that requires re-operation. Localizing studies in these patients have been clearly shown to reduce operating time, avoid unnecessary dissection, reduce morbidity, and improve success rate.

Several modalities have been employed for localization such as ultrasound (US), computed tomography (CT), and magnetic resonance imaging (MRI). The sensitivity of ultrasound for the preoperative detection of parathyroid adenomas has been reported to be 65-90% (1). There are however, limitations to US. Because of the sonolucent appearance of parathyroid adenomas, it is impossible to distinguish an ectopic cervical parathyroid adenoma from a pathologic lymph node. Furthermore, mediastinal parathyroid adenomas are difficult, if not impossible to visualize due to acoustic shadowing from the sternum and clavicles (2). Also, this method is very operator-dependent. MRI has a slightly higher sensitivity of 62.5-94% while CT has a poor sensitivity of only 40-44% (1).

We are using dual-phase single photon emission tomography (SPECT) imaging with technetium 99m sestamibi and visual thyroid subtraction with technetium 99m as pertechnetate. This method can achieve sensitivities of 68-95% and specificities of 75-100% (1). SPECT imaging is dependent on the differential washout of sestamibi between normal thyroid tissue and abnormal parathyroid tissue. Theoretically, sestamibi will washout of normal thyroid tissue much more quickly than it will from abnormal parathyroid tissue. Therefore, SPECT imaging is usually performed immediately and then at 90 and 180 minutes after sestamibi injection. SPECT imaging, however, has several limitations, not the least of which is its inability to provide discrete anatomic detail.

In addition, we will use a control group of patients who have parathyroid adenomas but who have not yet had surgery to test the efficacy of our fusion software.

Our goal is to acquire MRI and SPECT imaging with fiducial markers and utilize fusion software to create a detailed anatomic map of the neck for more accurate localization of the lesion.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from the Health Care Clinic

Criteria

Inclusion Criteria:

  • Subjects who are 18 years and over
  • subjects who have had a failed parathyroidectomy and now presents with persistent hyperparathyroidism or recurrent hyperparathyroidism
  • 6 control patients with parathyroid adenomas who have not yet had surgery will be selected to test the efficacy of the software.

Exclusion Criteria:

  • Potential female subjects who are pregnant
  • Any potential subject who has an implanted metallic device, stent or staples
  • any subject weighing 300lb
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639405

Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Michele Lisi, MD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: Michele Lisi, MD, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00639405     History of Changes
Other Study ID Numbers: SUNYUMU 5260
Study First Received: March 12, 2008
Last Updated: April 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Parathyroid
MRI
SPECT

Additional relevant MeSH terms:
Adenoma
Neoplasms
Hyperparathyroidism
Parathyroid Diseases
Parathyroid Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on April 14, 2014