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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00639405
Enrollment
12
Registered
2008-03-20
Start date
2005-09-30
Completion date
2008-08-31
Last updated
2011-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parathyroid Diseases, Parathyroid Neoplasm

Keywords

Parathyroid, MRI, SPECT

Brief summary

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.

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.

Interventions

None listed

Sponsors

State University of New York - Upstate Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026