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Limited Neck FDG-PET Imaging for Indeterminate Thyroid Nodules

18 Years
Open (Enrolling)
Thyroid Neoplasms

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Trial Information

Limited Neck FDG-PET Imaging for Indeterminate Thyroid Nodules

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.

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

- 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 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

- Patient does not meet any of the inclusion criteria

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Determine the sensitivity and specificity of FDG-PET in identifying malignant thyroid nodules of follicular or indeterminate cytology.

Outcome Time Frame:

Approximately 6 weeks after surgery

Safety Issue:


Principal Investigator

Jeffrey F Moley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:

04-0757 / 201103045



Start Date:

August 2004

Completion Date:

September 2013

Related Keywords:

  • Thyroid Neoplasms
  • Thyroid Neoplasms
  • Positron Emission Tomography
  • 18FDG
  • Neoplasms
  • Thyroid Neoplasms
  • Thyroid Diseases
  • Thyroid Nodule



Washington University School of Medicine Saint Louis, Missouri  63110
St. Louis University School of Medicine Saint Louis, Missouri  63104
VAMC Kansas City, Missouri