Accuracy of FDG-PET Scanning to Diagnose Malignant Thyroid Nodules

NCT00537797 | Completed

• 1 other identifier: 04-0757 / 201103045
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Thyroid Neoplasms

Keywords

Thyroid Neoplasms; Positron Emission Tomography; 18FDG

Outcome Measures

Primary Outcomes (3)

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

  Approximately 6 weeks after surgery

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

  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.

  Approximately 6 weeks after surgery

Secondary Outcomes (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

  Approximately 6 weeks after surgery

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Interventions

FDG-PET Scan OTHER

Positron emission tomography with 18F-fluorodeoxyglucose

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (3)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

St. Louis University School of Medicine

St Louis, Missouri, United States

Location

VAMC

St Louis, Missouri, United States

Location

Related Publications (21)

• 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.

  PMID: 10436189 BACKGROUND

• 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.

  PMID: 10638402 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 8907682 BACKGROUND

• 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.

  PMID: 10720047 BACKGROUND

• 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.

  PMID: 8211687 BACKGROUND

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

  PMID: 3511551 BACKGROUND

• 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.

  PMID: 2588125 BACKGROUND

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

  PMID: 7675472 BACKGROUND

• 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.

  PMID: 3673463 BACKGROUND

• 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.

  PMID: 11323510 BACKGROUND

• 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.

  PMID: 11886341 BACKGROUND

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

  PMID: 2013803 BACKGROUND

• 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.

  PMID: 8929320 BACKGROUND

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

  PMID: 8257858 BACKGROUND

• Grunwald F, Kalicke T, Feine U, Lietzenmayer R, Scheidhauer K, Dietlein M, Schober O, Lerch H, Brandt-Mainz K, Burchert W, Hiltermann G, Cremerius U, Biersack HJ. Fluorine-18 fluorodeoxyglucose positron emission tomography in thyroid cancer: results of a multicentre study. Eur J Nucl Med. 1999 Dec;26(12):1547-52. doi: 10.1007/s002590050493.

  PMID: 10638405 BACKGROUND

• Feine U, Lietzenmayer R, Hanke JP, Held J, Wohrle H, Muller-Schauenburg W. Fluorine-18-FDG and iodine-131-iodide uptake in thyroid cancer. J Nucl Med. 1996 Sep;37(9):1468-72.

  PMID: 8790195 BACKGROUND

• Cohen MS, Arslan N, Dehdashti F, Doherty GM, Lairmore TC, Brunt LM, Moley JF. Risk of malignancy in thyroid incidentalomas identified by fluorodeoxyglucose-positron emission tomography. Surgery. 2001 Dec;130(6):941-6. doi: 10.1067/msy.2001.118265.

  PMID: 11742321 BACKGROUND

• Allal AS, Dulguerov P, Allaoua M, Haenggeli CA, El-Ghazi el A, Lehmann W, Slosman DO. Standardized uptake value of 2-[(18)F] fluoro-2-deoxy-D-glucose in predicting outcome in head and neck carcinomas treated by radiotherapy with or without chemotherapy. J Clin Oncol. 2002 Mar 1;20(5):1398-404. doi: 10.1200/JCO.2002.20.5.1398.

  PMID: 11870185 BACKGROUND

• Yasuda S, Shohtsu A, Ide M, Takagi S, Takahashi W, Suzuki Y, Horiuchi M. Chronic thyroiditis: diffuse uptake of FDG at PET. Radiology. 1998 Jun;207(3):775-8. doi: 10.1148/radiology.207.3.9609903.

  PMID: 9609903 BACKGROUND

• 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.

  BACKGROUND

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Jeffrey F Moley, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: October 1, 2007
• Study Start: August 1, 2004
• Primary Completion: September 1, 2011
• Study Completion: February 1, 2014
• Last Updated: September 22, 2014

Record last verified: 2014-09

Locations

US (3)