Accuracy of FDG-PET Scanning to Diagnose Malignant Thyroid Nodules

September 18, 2014 updated by: Washington University School of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • St. Louis, Missouri, United States
        • St. Louis University School of Medicine
      • St. Louis, Missouri, United States
        • VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Approximately 6 weeks after surgery
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
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.
Time Frame: Approximately 6 weeks after surgery
Approximately 6 weeks after surgery

Secondary Outcome Measures

Outcome Measure
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
Time Frame: Approximately 6 weeks after surgery
Approximately 6 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Jeffrey F Moley, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 28, 2007

First Submitted That Met QC Criteria

September 30, 2007

First Posted (Estimate)

October 1, 2007

Study Record Updates

Last Update Posted (Estimate)

September 22, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-0757 / 201103045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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