Accuracy of FDG-PET Scanning to Diagnose Malignant Thyroid Nodules

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00537797
First received: September 28, 2007
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Thyroid Neoplasms
Other: FDG-PET Scan

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Limited Neck FDG-PET Imaging for Indeterminate Thyroid Nodules

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Determine the sensitivity and specificity of FDG-PET in identifying malignant thyroid nodules of follicular or indeterminate cytology. [ Time Frame: Approximately 6 weeks after surgery ] [ Designated as safety issue: No ]
  • Estimate positive and negative predictive value of FDG-PET in identifying malignant thyroid nodules of follicular or indeterminate cytology. [ Time Frame: Approximately 6 weeks after surgery ] [ Designated as safety issue: No ]
  • Estimate false positive rate and false negative rate of FDG-PET in identifying malignant thyroid nodules of follicular or indeterminate cytology. [ Time Frame: Approximately 6 weeks after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Approximately 6 weeks after surgery ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: August 2004
Estimated Study Completion Date: May 2014
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1

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

Other: FDG-PET Scan
Positron emission tomography with 18F-fluorodeoxyglucose

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537797

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
VAMC
St. Louis, Missouri, United States
St. Louis University School of Medicine
St. Louis, Missouri, United States
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jeffrey F Moley, MD Washington University School of Medicine
  More Information

Additional Information:
Publications:
Jana, S., H.M. Abdel-Dayem, and I. Young, Nuclear medicine and thyroid cancer. Eur J Nucl Med, 1999. 26(12): p. 1528-32.
Mazzaferi, 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.
Galloway, R.J. and R.C. Smallridge, Imaging in thyroid cancer. Endocrinol Metab Clin North Am, 1996. 25(1): p. 93-113.
Bell, R.M., Thyroid carcinoma. Surg Clin North Am, 1986. 66(1): p. 13-30.
Goellner, J.R., et al., Fine needle aspiration cytology of the thyroid, 1980 to 1986. Acta Cytol, 1987. 31(5): p. 587-90.
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.

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00537797     History of Changes
Other Study ID Numbers: 04-0757 / 201103045
Study First Received: September 28, 2007
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Thyroid Neoplasms
Positron Emission Tomography
18FDG

Additional relevant MeSH terms:
Neoplasms
Thyroid Neoplasms
Thyroid Diseases
Thyroid Nodule
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 19, 2014