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The main purpose of this study is to see how well FDG-PET scans can determine the malignancy of thyroid nodules that have already been tested (and come back positive) by fine needle aspiration.
While FNA is a sensitive test for diagnosing thyroid tumors, it cannot differentiate benign from malignant follicular nodules and sometimes yields equivocal results due to inadequate sampling or indeterminate cytology. The standard of care for patients with equivocal or follicular histology is surgical removal of these nodules, most of which are benign in nature. FDG-PET, as evidenced by our prior experience and studies from other groups, may have application in discriminating benign from malignant disease in these patients with equivocal or follicular FNA results using standardized uptake value determination. We have demonstrated the feasibility and preliminary clinical utility of using limited neck FDG-PET exams in patients with indeterminate thyroid nodules in a pilot study. The purpose of this trial is to prospectively evaluate a larger series of patients with equivocal or follicular histology on FNA to more accurately define the sensitivity and specificity of FDG-PET for diagnostic imaging of these nodules. In addition, the utility of this modality in identifying metastatic foci in patients with thyroid cancer having follicular or equivocal histology on FNA will be assessed. If the sensitivity and specificity of this modality are determined to be high (≥95%) for diagnosing malignant nodules in these patients, many patients with benign disease may potentially benefit by avoiding unnecessary operations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 18-FDG-PET exam with SUV determination Thyroid operation to remove nodule Pathologic confirmation of nodule histology Determine sensitivity and specificity of FDG-PET, correlative studies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDG-PET Scan | Other | Positron emission tomography with 18F-fluorodeoxyglucose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the sensitivity and specificity of FDG-PET in identifying malignant thyroid nodules of follicular or indeterminate cytology. | Approximately 6 weeks after surgery | |
| Estimate positive and negative predictive value of FDG-PET in identifying malignant thyroid nodules of follicular or indeterminate cytology. | Approximately 6 weeks after surgery | |
| Estimate false positive rate and false negative rate of FDG-PET in identifying malignant thyroid nodules of follicular or indeterminate cytology. | Approximately 6 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the sensitivity of the FDG-PET/CT imaging in localizing foci of metastatic disease within the neck in patients with thyroid malignancy identified as having follicular or equivocal histology by FNA | Approximately 6 weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey F Moley, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States | ||
| St. Louis University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10436189 | Background | Lind P. Multi-tracer imaging of thyroid nodules: is there a role in the preoperative assessment of nodular goiter? Eur J Nucl Med. 1999 Aug;26(8):795-7. doi: 10.1007/s002590050450. No abstract available. | |
| 10638402 | Background | Jana S, Abdel-Dayem HM, Young I. Nuclear medicine and thyroid cancer. Eur J Nucl Med. 1999 Dec;26(12):1528-32. doi: 10.1007/s002590050490. No abstract available. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| St Louis |
| Missouri |
| United States |
| VAMC | St Louis | Missouri | United States |
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| 2013803 | Background | Strauss LG, Conti PS. The applications of PET in clinical oncology. J Nucl Med. 1991 Apr;32(4):623-48; discussion 649-50. |
| 8929320 | Background | Rigo P, Paulus P, Kaschten BJ, Hustinx R, Bury T, Jerusalem G, Benoit T, Foidart-Willems J. Oncological applications of positron emission tomography with fluorine-18 fluorodeoxyglucose. Eur J Nucl Med. 1996 Dec;23(12):1641-74. doi: 10.1007/BF01249629. |
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| 10638405 | Background | Grunwald F, Kalicke T, Feine U, Lietzenmayer R, Scheidhauer K, Dietlein M, Schober O, Lerch H, Brandt-Mainz K, Burchert W, Hiltermann G, Cremerius U, Biersack HJ. Fluorine-18 fluorodeoxyglucose positron emission tomography in thyroid cancer: results of a multicentre study. Eur J Nucl Med. 1999 Dec;26(12):1547-52. doi: 10.1007/s002590050493. |
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| Background | Xu M, L.W., Cutler PD, Digby WM, Local threshold for segmented attenuation correction of PET imaging of the thorax. IEEE Trans Nuc Sci 1994. 41: p. 1532-7. |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |