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

March 12, 2008
April 26, 2011
September 2005
August 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00639405 on ClinicalTrials.gov Archive Site
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Evaluation of MRI and SPECT Fusion Software to Localize Parathyroid Adenomas
Localization of Parathyroid Adenomas Using MRI and SPECT Fusion Software in Patients With Persistent or Recurrent Hyperparathyroidism

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Subjects will be recruited from the Health Care Clinic

  • Parathyroid Neoplasm
  • Parathyroid Diseases
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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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00639405
SUNYUMU 5260
No
Michele Lisi, MD, SUNY Upstate Medical University
State University of New York - Upstate Medical University
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Principal Investigator: Michele Lisi, MD State University of New York - Upstate Medical University
State University of New York - Upstate Medical University
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP