Principal Site Investigator ENHANCE (Evaluation of Thyroid FNA Genomic Signature) study: An IRB approved study with funding to Rochester Regional

Transcription

1 October 20 th 2018

2 Principal Site Investigator ENHANCE (Evaluation of Thyroid FNA Genomic Signature) study: An IRB approved study with funding to Rochester Regional Health from Veracyte

3 Review ultrasound imaging characteristics for the assessment of risk of malignancy in thyroid nodules Discuss current guidelines for ultrasound guided fine needle aspiration of thyroid nodules Incorporate the clinical status of the patient in the decision to needle biopsy

4 Accessed 9/13/2018

5 Common types of cancer Estimated new cases 2018 Estimated deaths Breast cancer Lung and bronchus cancer Prostate cancer Colon and rectum cancer Melanoma of the skin Bladder cancer Non-Hodgkin Lymphoma Kidney & Renal pelvis cancer Endometrial cancer Leukemia Pancreatic Cancer Thyroid cancer Accessed 09/02/18

6 Accurately define the risk that a nodule is cancerous Accurately define risk to a patient from cancer Accurately define the risk of potentially unnecessary surgery

7 Thyroid cancer in one or more first degree relatives External beam radiation in childhood Ionizing radiation in childhood or adolescence Prior thyroid surgery with history of thyroid cancer FDG avidity on PET scanning RET oncogene mutation Calcitonin > 100 pg/ml

8 Hard or fixed nodule Cervical adenopathy Persistent dysphonia

9 FIRST STEP TSH American Thyroid Association Management Guidelines for Patients With Thyroid Nodules and Differentiated Thyroid Cancer, 2009

10 Thyroid Ultrasound Check TSH TSH Suppressed TSH Normal or High Thyroid scan Cooper DS et al. Thyroid. 2009;19(11): Fine needle aspiration

11 Adjusted Odds Ratio For Thyroid Cancer 0 < TSH (miu/l) K. Boelaert, J Clin Endocrinol Metab : > 5.5

12 McCall (1998) Definition of nodularity scan/ histology FNA technique Cancer 1 nodule MNG palpation 17% 13% Belfiore (1992) scan palpation 5% 5% Cochand (1994) scan/us US 13% 14% Sachmechi (2000) scan palpation 8% 10% Marqusee (2000) US US 7% 9% Papini (2002) US US 9% 6% Deandrea (2002) US US 6% 7% Cappelli (2005) US US 9% 9% Frates (2006) US US 15% 15% McCall, Surgery 1998; Belfiore, Am J Med 1992; Cochand-Priollet, Am J Med 1994; Sachmechi, Endocr Pract 2000; Marquesee, Ann Intern Med 2000; Papini, JCEM 2002; Deandrea, Endocr Pract 2002; Cappelli, Clin Endocrinol 2005; Frates, JCEM 2006

13 Echogenicity: (Hypo, iso, hyper) Calcifications: (Micro, macro, eggshell) Margins: (Infiltrative, well defined) Shape: (Taller than wide) Size

14 Hyperecholc

15 Kim et al. AJR 2002;178: Hypo-echogenicity confers a sensitivity of 81% and specificity of 53 % for thyroid cancer Most papillary cancers are hypo-echoic However since benign nodules are more common, most hypoechoic nodules are benign

16 Multiple bright punctate (< 1 mm without shadowing) Specificity of 86-95% for papillary thyroid cancers Positive predictive value: 42-94% Kwak JY et al. Radiology : Salmaslioglu A et al. World J Surg : Moon WJ et al. Radiology 2008;247:

17 Sensitivity: 32%, Specificity: 92% PPV; 62% for papillary thyroid cancer Measured in the transverse plane Cappelli C, et al. Clin Endocrinol (Oxf ) 2005; 63: ; Lee JH et al. J Ultrasound Med 2015; 34:1 15

18 An irregular, infiltrating or lobular margin is suggestive of thyroid cancer The halo sign - a hypo-echoic or anechoic rim surrounding a nodule suggests benignity, however, this sign is absent in more than 50% of benign nodules and present in up to 20% of malignant nodules

19 Accurate sizing of thyroid nodules is critical, as the maximum dimension determines whether a given lesion should be biopsied or followed. Nodules should be measured in three axes: (1) maximum dimension on an axial image, (2) maximum dimension perpendicular to the previous measurement on the same image, and (3) maximum longitudinal dimension on a sagittal image

20 Meticulous documentation of the location of nodules on sonograms is very important, particularly when the thyroid gland is heterogeneous or multiple nodules are present. Currently there is no uniform system to document nodule location ; terminologies include mid medial and mid lateral

21 BASELINE RISK Variable Clinical Age < 25 yrs Male Sex High Risk Clinical Finding Radiologic >75% cystic parenchyma Single high risk US feature 2 or more HR US features FDG-PET uptake I 123 uptake High risk elastography 0% 10 20% 30% 40% 50% 60% 70% 80% 90% 100% % Clinical Utility High High Low High High High Low Moderate Unknown Adapted from: Alexander EK. J Clin Endocrinol Metab 2008;93:

22 Risk of malignancy High suspicion > % Intermediate suspicion > % Low suspicion > 5-10 % Very low suspicion > 5 % Benign <1 %

23 Sonographic Pattern US Features Estimated Risk of Malignancy % FNA size cutoff (largest dimension) High suspicion Solid hypoechoic nodule or solid hypoechoic component of a partially cystic nodule with one or more of the following features: irregular margins (infiltrative, microlobulated), microcalcifications, taller than wide shape, rim calcifications with small extrusive soft tissue component, evidence of extra thyroidal extension >70 90 Recommend FNA at 1 cm

24 Sonographic Pattern US Features Estimated Risk of Malignancy % FNA size cutoff (largest dimension) Intermediate suspicion Hypoechoic solid nodule with smooth margins without microcalcifications, ETE, or taller than wide shape Recommend FNA at 1 cm Low suspicion Isoechoic or hyperechoic solid nodule, or partially cystic nodule with eccentric solid areas, without microcalcification, irregular margin or ETE, or taller than wide shape Recommend FNA at 1.5 cm

25 Sonographic Pattern US Features Estimated Risk of Malignancy % FNA size cutoff (largest dimension) Very low suspicion Spongiform or partially cystic nodules with- out any of the sonographic features de- scribed in low, intermediate, or high suspicion patterns <3 Consider FNA at 2 cm Observation without FNA is also a reasonable option Benign Purely cystic nodules (no solid component) <1 No biopsy

26 AACE/ACE-AME Guidelines Low RIsk Intermediate RIsk High Risk ATA Guidelines Benign Very Low Suspicion Low Suspicion Intermediate suspicion High Suspicion

27 The ultrasound features in the ACR TI-RADS are categorized as benign, not suspicious, mildlly suspicious, moderately suspicious, or highly suspicious for malignancy. Points are given for all the ultrasound features in a nodule, with more suspicious features being awarded additional points. When assessing a nodule, the reader selects one feature from each of the first four categories and all the features that apply from the final category and sums the points. The point total determines the nodule s ACR TI-RADS level, which ranges from TR1 (benign) to TR5 (high suspicion of malignancy). Tessler FN et al. J Am Coll Radiol 2017;14:

28 Tessler FN et al. J Am Coll Radiol 2017;14:

29 The ACR TI-RADS lends itself to implementation as templates in voice recognition reporting or computerized decision support systems. Both TIRADS and the ATA guidelines provide effective malignancy risk stratification for thyroid nodules. Nodules that do not meet the criteria for a specifc pattern with the ATA guidelines have a relatively high risk of malignancy (18.2%). The thresholds for mildly suspicious and moderately suspicious nodules (2.5 and 1.5 cm, respectively) are higher than the cutoffs advocated by the ATA and the Korean Society of Thyroid Radiology Yoon et al. Radiology: 2016: 278 (3); Shin JH et al. Korean J Radiol 2016;17:

30 Sonographic Pattern Descriptive Term FNA size cutoff (Largest dimension) Sonographic Pattern Descriptive Term FNA size cutoff (Largest dimension) ATA 1 Benign No FNA TR 1 Benign No FNA ATA 2 ATA 3 ATA 4 ATA 5 Very Low Suspicion Low Suspicion Intermediate Suspicion High Suspicion 2.0 cm TR 2 Not Suspicious 1.5 cm TR 3 Mildly Suspicious 1.0 cm TR 4 Moderately Suspicious 1.0 cm TR 5 Highly Suspicious No FNA 2.5 cm 1.5 cm 1.0 cm Tessler FN et al. J Am Coll Radiol 2017;14:

31 Diagnostic yield of sequential aspiration strategies in 120 patients with multiple nodules and cancer FNA performed on No. of nodules > 10 mm 2 (n=73) 3 (n=27) Largest nodule Largest 2 nodules Largest 3 nodules Largest 4 nodules 100 For exclusion of cancer in a thyroid with multiple nodules larger than 10 mm, up to four nodules should be considered for FNA Sonographic characteristics can be used to prioritize nodules for FNA based on their individual risk of cancer Frates MC et al. J Clin Endocrinol Metab. 2006;91:

32 ATA: Most thyroid nodules meeting the preceding sonographic patterns and sizes should undergo FNA AACE/ACE-AME: We do not recommend the biopsy of more than 2 nodules when they are selected on the basis of previously described criteria

33 Biopsy of three or more nodules is poorly tolerated by patients and increases cost with little or no benefit and some added risk. The ACR recommends targeting no more than two nodules with the highest ACR TI-RADS point totals that meet criteria for FNA. We discourage usage of the term dominant nodule, which is often applied to the largest lesion in the gland, because it downplays the primary role of architecture in determining management. FNA of suspicious nodes, in addition to up to two nodules that warrant biopsy on the basis of the ACR TI-RADS. Tessler FN et al. J Am Coll Radiol 2017;14: ;

34 Multi-nodular goiters with a low TSH Graves disease with thyroid nodules Sub-acute thyroiditis and pseudo-nodules Retrosternal goiters with suspicious features

35 Original Ultrasound image Detection and qualitative diagnosis of a thyroid nodule using Deep Learning inferencing