METHODS: The study participants consisted of patients with an axillary temperature ≥ 38.0 °C on ≥ 2 occasions within 1 week, with repeated episodes for ≥ 2 weeks prior to providing consent, and whose final diagnosis after undergoing specific examinations, including a chest-to-abdomen CT scan, was uncertain. All the patients underwent FDG-PET/CT imaging first, followed by 67Ga-SPECT imaging within 3 days. The results of the FDG-PET/CT and 67Ga-SPECT examinations were reviewed by the central image interpretation committee (CIIC), which was blinded to all other clinical information. The sensitivities of FDG-PET/CT and 67Ga-SPECT were then evaluated with regard to identifying the site of greatest importance for a final diagnosis of the cause of the fever as decided by the patient\'s attending physician. The clinical impacts (four grades) of FDG-PET/CT and 67Ga-SPECT on the final diagnosis were evaluated.
RESULTS: A total of 149 subjects were enrolled in this study between October 2014 and September 2017. No adverse events were identified among the enrolled subjects. Twenty-one subjects were excluded from the study because of deviations from the study protocol. Among the 128 remaining subjects, a final diagnosis of the disease leading to the appearance of FUO was made for 92 (71.9%) subjects. The final diagnoses in these 92 cases were classified into four groups: noninfectious inflammatory disease (52 cases); infectious disease (31 cases), malignancy (six cases); and other (three cases). These 92 subjects were eligible for inclusion in the study\'s analysis, but one case did not meet the PET/CT image acquisition criteria; thus, PET/CT results were analyzed for 91 cases. According to the patient-based assessments, the sensitivity of FDG-PET/CT (45%, 95% CI 33.1-58.2%) was significantly higher than that for 67Ga-SPECT (25%, 95% CI 15.5-37.5%) (P = 0.0029). The clinical impact of FDG-PET/CT (91%) was also significantly higher than that for 67Ga-SPECT (57%, P < 0.001).
CONCLUSIONS: FDG-PET/CT showed a superior sensitivity to 67Ga-SPECT for the identification of the site of greatest importance for the final diagnosis of the cause of FUO.
方法:研究参与者包括1周内腋窝温度≥38.0°C的患者,在提供同意前反复发作≥2周,经过特殊检查后的最终诊断,包括胸部到腹部的CT扫描,不确定。所有患者均先行FDG-PET/CT显像,随后在3天内进行67Ga-SPECT成像。中央影像解读委员会(CIIC)对FDG-PET/CT和67Ga-SPECT检查结果进行了评审,对所有其他临床信息都是不知情的。然后评估FDG-PET/CT和67Ga-SPECT的敏感性,以确定对患者主治医师决定的发热原因的最终诊断最重要的部位。评估FDG-PET/CT和67Ga-SPECT对最终诊断的临床影响(四个等级)。
结果:2014年10月至2017年9月,本研究共纳入149名受试者。在登记的受试者中没有发现不良事件。由于与研究方案的偏差,21名受试者被排除在研究之外。在剩下的128个科目中,对92名(71.9%)受试者进行了导致FUO出现的疾病的最终诊断.92例患者的最终诊断分为四组:非感染性炎症性疾病(52例);感染性疾病(31例),恶性肿瘤(6例);和其他(3例)。这92名受试者有资格纳入研究分析,但有一例不符合PET/CT图像采集标准;因此,分析91例PET/CT检查结果。根据基于患者的评估,FDG-PET/CT的敏感性(45%,95%CI33.1-58.2%)显著高于67Ga-SPECT(25%,95%CI15.5-37.5%)(P=0.0029)。FDG-PET/CT的临床影响(91%)也显着高于67Ga-SPECT(57%,P<0.001)。
结论:FDG-PET/CT在鉴定对最终诊断FUO病因最重要的部位方面比67Ga-SPECT具有更高的敏感性。