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Thyroid NeoplasmsNCT00537797

Accuracy of FDG-PET Scanning to Diagnose Malignant Thyroid Nodules

A study testing FDG-PET Scan in people with Thyroid Neoplasms, run by Washington University School of Medicine at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Neoplasms
What is being tested?
FDG-PET Scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
3 sitesUnited States
Study dates
Aug 2004to Feb 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)
Show all 10Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • St. Louis University School of Medicine

    St Louis, Missouri

  • VAMC

    St Louis, Missouri

Other trials in United States

About this study

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.

Read the 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.

Being tested
FDG-PET Scan
Keywords
Thyroid Neoplasms, Positron Emission Tomography, 18FDG
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FDG-PET ScanOther

    Positron emission tomography with 18F-fluorodeoxyglucose

Study groups in NCT00537797
Study groupRoleWhat they receive
Arm 1Experimental18-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
Receives: Other: FDG-PET Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Approximately 6 weeks after surgery

  2. Estimate positive and negative predictive value of FDG-PET in identifying malignant thyroid nodules of follicular or indeterminate cytology.

    Measured: Approximately 6 weeks after surgery

  3. Estimate false positive rate and false negative rate of FDG-PET in identifying malignant thyroid nodules of follicular or indeterminate cytology.

    Measured: Approximately 6 weeks after surgery

Secondary outcomes (1)

  1. 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

    Measured: Approximately 6 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2007 (estimated)
  2. Study startAug 2004
  3. Primary completionSep 2011
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00537797
Sponsor's protocol ID
04-0757 / 201103045
Status last verified
Sep 2014
First submitted
28 Sep 2007
Last updated
22 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • Lind P. Multi-tracer imaging of thyroid nodules: is there a role in the preoperative assessment of nodular goiter? Eur J Nucl Med. 1999 Aug;26(8):795-7. doi: 10.1007/s002590050450. No abstract available.

    PubMed 10436189

  • Jana 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.

    PubMed 10638402

  • 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 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.

    PubMed 8907682

  • Wang 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.

    PubMed 10720047

  • Bloom 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.

    PubMed 8211687

  • Bell RM. Thyroid carcinoma. Surg Clin North Am. 1986 Feb;66(1):13-30. doi: 10.1016/s0039-6109(16)43827-2.

    PubMed 3511551

  • Grant 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.

    PubMed 2588125

  • Yousem DM, Scheff AM. Thyroid and parathyroid gland pathology. Role of imaging. Otolaryngol Clin North Am. 1995 Jun;28(3):621-49.

    PubMed 7675472

  • Goellner JR, Gharib H, Grant CS, Johnson DA. Fine needle aspiration cytology of the thyroid, 1980 to 1986. Acta Cytol. 1987 Sep-Oct;31(5):587-90.

    PubMed 3673463

  • Udelsman R, Westra WH, Donovan PI, Sohn TA, Cameron JL. Randomized prospective evaluation of frozen-section analysis for follicular neoplasms of the thyroid. Ann Surg. 2001 May;233(5):716-22. doi: 10.1097/00000658-200105000-00016.

    PubMed 11323510

  • Roach JC, Heller KS, Dubner S, Sznyter LA. The value of frozen section examinations in determining the extent of thyroid surgery in patients with indeterminate fine-needle aspiration cytology. Arch Otolaryngol Head Neck Surg. 2002 Mar;128(3):263-7. doi: 10.1001/archotol.128.3.263.

    PubMed 11886341

  • Strauss LG, Conti PS. The applications of PET in clinical oncology. J Nucl Med. 1991 Apr;32(4):623-48; discussion 649-50.

    PubMed 2013803

  • Rigo P, Paulus P, Kaschten BJ, Hustinx R, Bury T, Jerusalem G, Benoit T, Foidart-Willems J. Oncological applications of positron emission tomography with fluorine-18 fluorodeoxyglucose. Eur J Nucl Med. 1996 Dec;23(12):1641-74. doi: 10.1007/BF01249629.

    PubMed 8929320

  • Adler LP, Bloom AD. Positron emission tomography of thyroid masses. Thyroid. 1993 Fall;3(3):195-200. doi: 10.1089/thy.1993.3.195.

    PubMed 8257858

Questions about this trial

What is this clinical trial studying?

A study testing FDG-PET Scan in people with Thyroid Neoplasms, run by Washington University School of Medicine at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00537797, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2014.

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