Artificial intelligence-based CT-free quantitative thyroid SPECT for thyrotoxicosis: study protocol of a multicentre, prospective, non-inferiority study

• Published in: BMJ open Vol. 14; no. 10; p. e089552
• Main Authors: Oh, Dongkyu, Ryoo, Hyun Gee, Chung, Hyun Woo, Cho, Sang-Geon, Kwon, Kyounghyoun, Kim, Ji Hye, So, Young, Moon, Jae Hoon, Ahn, Soyeon, Lee, Won Woo
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 14.10.2024; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: Adult; Artificial Intelligence; Bioassays; clinical trial; computed tomography; Diagnosis, Differential; Equivalence Trials as Topic; Female; Graves disease; Graves Disease - diagnostic imaging; Hospitals; Humans; Hyperthyroidism; Immunoglobulins; Iodine; Male; Multicenter Studies as Topic; nuclear medicine; nuclear radiology; Prospective Studies; Protocol; Radiation; Radiology and Imaging; Republic of Korea; Scintigraphy; Single Photon Emission Computed Tomography Computed Tomography - methods; Single-Blind Method; thyroid disease; Thyroid diseases; Thyroid Gland - diagnostic imaging; Thyroiditis - diagnostic imaging; Thyrotoxicosis - diagnostic imaging; Tomography, Emission-Computed, Single-Photon - methods; Ultrasonic imaging; Republic of Korea; clinical trial; computed tomography; thyroid disease; nuclear medicine; nuclear radiology; artificial intelligence
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2024-089552

IntroductionTechnetium thyroid uptake (TcTU) measured by single-photon emission CT/CT (SPECT/CT) is an important diagnostic tool for the differential diagnosis of Graves’ disease and destructive thyroiditis. Artificial intelligence (AI) may reduce CT-induced radiation exposure by substituting the role of CT in attenuation correction (AC) and thyroid segmentation, thus realising CT-free SPECT. This study aims to compare the diagnostic accuracy for the differential diagnosis of thyrotoxicosis between CT-free SPECT and SPECT/CT.Methods and analysisThe AI-based CT-free SPECT is a single-blind, multicentre, prospective, non-inferiority, clinical trial with a paired design conducted in the Republic of Korea. Eligible participants are adult (≥19 years old) thyrotoxicosis patients without a previous history of hyperthyroidism or hypothyroidism. Approximately 160 subjects will be screened for quantitative thyroid SPECT/CT using Tc-99m pertechnetate. CT-free thyroid SPECT will be realised using only SPECT data by the trained convolutional neural networks. TcTU will be calculated by SPECT/CT and CT-free SPECT in each subject. The primary endpoint is the accuracy of diagnosing Graves’ disease using TcTU. The trial will continue until 152 completed datasets have been enrolled to assess whether the 95% (two-sided) lower confidence limit of the accuracy difference (CT-free SPECT accuracy—SPECT/CT accuracy) for Graves’ disease is greater than −0.1. The secondary endpoints include the accuracy of diagnosing destructive thyroiditis and predicting the need for antithyroid drug prescription within 1 month of the SPECT/CT.Ethics and disseminationThe study protocol has been approved by the institutional review board of Seoul National University Bundang Hospital (IRB No. B-2304-824-301), Konkuk University Medical Center (IRB No. 2023-05-022-006) and Chonnam National University Hospital (IRB No. CNUH-2023-108). Findings will be disseminated as reports, presentations and peer-reviewed journal articles.Trial registration numberKCT0008387, Clinical Research Information Service of the Republic of Korea (CRIS).