Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
State University of New York - Upstate Medical University |
---|---|
Information provided by: | State University of New York - Upstate Medical University |
ClinicalTrials.gov Identifier: | NCT00639405 |
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: | Case-Only, Prospective |
Official Title: | Localization of Parathyroid Adenomas Using MRI and SPECT Fusion Software in Patients With Persistent or Recurrent Hyperparathyroidism |
Estimated Enrollment: | 31 |
Study Start Date: | September 2005 |
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.
|
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Subjects will be recruited from the Health Care Clinic
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
SUNY Upstate Medical University | |
Syracuse, New York, United States, 13210 |
Principal Investigator: | Michele Lisi, MD | State University of New York - Upstate Medical University |
Responsible Party: | SUNY Upstate Medical University ( Michele Lisi, MD ) |
Study ID Numbers: | SUNYUMU 5260 |
Study First Received: | March 12, 2008 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00639405 |
Health Authority: | United States: Institutional Review Board |
Parathyroid MRI SPECT |
Parathyroid Diseases Parathyroid Neoplasms Hyperparathyroidism Head and Neck Neoplasms Endocrine System Diseases |
Endocrinopathy Adenoma Recurrence Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site |