Clinical trial · Interventional
Accuracy of FDG-PET Scanning to Diagnose Malignant Thyroid Nodules
Limited Neck FDG-PET Imaging for Indeterminate Thyroid Nodules
NCT00537797CI-TRIAL-00015670completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Neoplasms | Thyroid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDG-PET Scan | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- 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
- interventionNames
- Other: FDG-PET Scan
Primary outcomes (3)
- measure
- Determine the sensitivity and specificity of FDG-PET in identifying malignant thyroid nodules of follicular or indeterminate cytology.
- timeFrame
- Approximately 6 weeks after surgery
- measure
- Estimate positive and negative predictive value of FDG-PET in identifying malignant thyroid nodules of follicular or indeterminate cytology.
- timeFrame
- Approximately 6 weeks after surgery
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (21)
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- BACKGROUNDJana 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. PMID 10638402
- BACKGROUNDMazzaferi, E., Radioiodine and other treatments and outcomes. Werner & Ingbar's the thyroid : a fundamental and clinical text ; editors, Lewis E. Braverman, Robert D. Utiger., 1996. 7th edn. Philadelphia: J.B. Lippincott-Raven: p. 922-943.
- BACKGROUNDGalloway RJ, Smallridge RC. Imaging in thyroid cancer. Endocrinol Metab Clin North Am. 1996 Mar;25(1):93-113. doi: 10.1016/s0889-8529(05)70314-5. PMID 8907682
- BACKGROUNDWang W, Larson SM, Fazzari M, Tickoo SK, Kolbert K, Sgouros G, Yeung H, Macapinlac H, Rosai J, Robbins RJ. Prognostic value of [18F]fluorodeoxyglucose positron emission tomographic scanning in patients with thyroid cancer. J Clin Endocrinol Metab. 2000 Mar;85(3):1107-13. doi: 10.1210/jcem.85.3.6458. PMID 10720047
- BACKGROUNDBloom AD, Adler LP, Shuck JM. Determination of malignancy of thyroid nodules with positron emission tomography. Surgery. 1993 Oct;114(4):728-34; discussion 734-5. PMID 8211687
- BACKGROUNDBell RM. Thyroid carcinoma. Surg Clin North Am. 1986 Feb;66(1):13-30. doi: 10.1016/s0039-6109(16)43827-2. PMID 3511551
- BACKGROUNDGrant CS, Hay ID, Gough IR, McCarthy PM, Goellner JR. Long-term follow-up of patients with benign thyroid fine-needle aspiration cytologic diagnoses. Surgery. 1989 Dec;106(6):980-5; discussion 985-6.