Thyroid Neoplasms Clinical Trial
Official title:
Limited Neck FDG-PET Imaging for Indeterminate Thyroid Nodules
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | February 2014 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Documented history of a solitary thyroid nodule or a dominant nodule within multinodular disease, with fine needle aspiration demonstrating a follicular or indeterminate cytologic examination. If a core needle biopsy was performed instead of a fine needle aspiration, demonstrating follicular or indeterminate cytology, the patient is eligible if the biopsy procedure was felt to be minimally disruptive to the nodule architecture, based on a review by the PI or nuclear medicine investigator. - Thyroid nodule must be palpable on physical examination or have a minimum size of 1 cm in diameter by ultrasonography, CT or MRI. The minimum size criterion was established to address the spatial resolution limitations of PET/CT imaging. - Scheduled for surgical excision of thyroid nodules within 3 months of the date of the FDG-PET/CT scan. - Ability to tolerate lying supine for a FDG-PET/CT examination. - Age >/= 18 and </= 105 (This disease is rare in children and therefore the study will be limited to adults.) - Willing to participate in all aspects of the study (patient may opt out of the tissue collection portion.) - Patient must be euthyroid with a serum TSH or a free T4 level within the institutional upper and lower limits of normal, measured within 6 months of registration. NOTE: mild deviations from the institutional normal limits may be considered acceptable if the patient has achieved a clinically euthyroid state with medication at a stable dose for >3 months, and the TSH is considered to be at target by the patient's treating physician. In patients with hyperthyroidism requiring treatment, this euthyroid state may be achieved with administration of a thionamide such as propylthiouracil prior to FDG-PET/CT exam. Patients with hyperthyroid inflammatory conditions such as thyroiditis and toxic multinodular goiter often exhibit increased glucose uptake resulting in diffuse uptake of FDG which may obscure visualization of a thyroid tumor. - If female, patient must have a negative pregnancy test at the time of registration, be post-menopausal (with no period in the last twelve months), have had a tubal ligation at least twelve months ago, or have had a hysterectomy. - In patients with multinodular disease and a dominant nodule, the nuclear medicine physician responsible for FDG-PET/CT scan interpretation must determine whether the indeterminate nodule can be discriminated on FDG-PET/CT imaging prior to enrollment. - A signed and dated written informed consent obtained from the patient or the patient's legally acceptable representative prior to study participation. Exclusion Criteria: - Patient has a fasting glucose level > 200 mg/dL at the time of the PET/CT scan - Patient has had prior neck surgery or radiation that in the opinion of the investigator has disrupted tissue architecture of the thyroid - Patient has evidence of infection localized to the neck in the 14 days prior to the FDG-PET/CCT scan - Patient does not meet any of the inclusion criteria |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | St. Louis University School of Medicine | St. Louis | Missouri |
United States | VAMC | St. Louis | Missouri |
United States | Washington University School of Medicine | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the sensitivity and specificity of FDG-PET in identifying malignant thyroid nodules of follicular or indeterminate cytology. | Approximately 6 weeks after surgery | No | |
Primary | Estimate positive and negative predictive value of FDG-PET in identifying malignant thyroid nodules of follicular or indeterminate cytology. | Approximately 6 weeks after surgery | No | |
Primary | 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 | No | |
Secondary | 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 | No |
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