Comparison of FDG-PET/CT and CECT-CAP as Upfront Imaging Modality for the Diagnosis of Pyrexia of Unknown Origin (CET-PET-PUO)
Comparison of FDG-PET/CT and CECT-CAP as Upfront Imaging Modality for the Diagnosis of Pyrexia of Unknown Origin : A Prospective Observational Study
Pyrexia of unknown origin (PUO) remains one of the most challenging diagnostic problems in modern medicine. Despite advances in laboratory diagnostics, microbiological techniques, imaging modalities, and molecular testing, a significant proportion of patients continue to undergo multiple, prolonged, expensive, and often invasive evaluations before a definitive diagnosis is established. PUO is classically defined as fever ≥38.3°C documented on ≥2 occasions AND duration ≥3 weeks or inpatient fever ≥1 week without diagnosis despite routine evaluation.
The etiological spectrum of PUO is broad and heterogeneous. Causes are traditionally grouped into infections, malignancies, non-infectious inflammatory diseases, miscellaneous causes, and undiagnosed cases. Despite systematic evaluation, a definitive diagnosis is not achieved in a substantial proportion of patients, often ranging from 30-50% even in tertiary care centers. This persistent diagnostic uncertainty highlights the need for effective diagnostic strategies that can identify occult disease early and guide targeted investigations.
Imaging plays a pivotal role once baseline routine investigations fail to establish a diagnosis. Conventional contrast-enhanced computed tomography (CECT) of the chest, abdomen, and pelvis is frequently used due to its wide availability and ability to detect structural abnormalities such as abscesses, masses, and lymphadenopathy. However, CECT relies on anatomical changes and may fail to identify early inflammatory or infiltrative disease that lacks overt structural distortion.
In contrast, nuclear medicine modalities enable the identification of pathological processes at the cellular and molecular level. 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) exploits abnormal glucose metabolism in inflammatory, infectious, and malignant tissues. When combined with PET/CT, it enables precise anatomical localization of metabolically active lesions. Numerous studies have shown that FDG PET/CT is valuable in the evaluation of PUO, especially when standard imaging modalities fail to yield a diagnosis.
In a retrospective study, FDG-PET/CT outperformed CECT-CAP for definite diagnosis of PUO with markedly higher localisation (92.2 vs. 51.5 %; p = 0.003). In a comparative multicentre prospective study FDG PET/CT demonstrated significantly superior diagnostic orientation (28.2% vs. 7.8%, p < 0.001) and diagnostic contribution (19.4% vs. 5.8%, p < 0.001) compared with CECT-CAP, and was associated with a markedly shorter time to definitive diagnosis (3.8 vs. 17.6 months, p = 0.02). However in these studies same patient underwent both FDG-PET/CT and CECT-CAP. In a systematic review, meta-analysis FDG PET/CT had pooled diagnostic yield of 56% and diagnostic yield beyond conventional CT at 32%. However another systematic review/meta-analysis similarly reported a higher contributory effect of FDG-PET/CT compared to Total Body CT (75.4% vs 68%,P = .39) for final diagnosis of PUO although it was not statistically significant. However both studies included data from retrospective studies.
Current clinical practice varies with respect to the timing and sequencing of FDG PET/CT and Conventional CECT in PUO evaluation. FDG PET/CT is often used as a second-line investigation after CECT-CAP or when CECT-CAP is inconclusive; however, growing evidence suggests that early use of FDG PET/CT may offer superior diagnostic yield and reduce diagnostic delay. However clear evidence from randomized controlled trials comparing FDG PET/CT and CECT-CAP as upfront investigations is lacking. This uncertainty forms the basis of clinical equipoise and provides the rationale for the present study. In this study we will evaluate and compare the diagnostic localization and diagnostic yield of FDG PET/CT over CECT-CAP for etiological diagnosis of PUO.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Deba Prasad Dhibar, MD
- 电话号码:+911722756670
- 邮箱:drdeba_prasad@yahoo.co.in
研究联系人备份
- 姓名:Anil Kumar, MBBS
- 电话号码:+911722756670
- 邮箱:anilkum13re@gmail.com
学习地点
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Chandigarh
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Chandigarh、Chandigarh、印度、160012
- 招聘中
- Post Graduate Institute of Medical Education and Research, Chandigarh, India
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首席研究员:
- Deba Prasad Dhibar, MD
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接触:
- Deba Prasad Dhibar, MD
- 电话号码:+911722756670
- 邮箱:drdeba_prasad@yahoo.co.in
-
接触:
- Anil Kumar, MBBS
- 电话号码:+911722756670
- 邮箱:anilkum13re@gmail.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age > 18 years
- irrespective of gender.
- Fever ≥38.3°C documented on ≥2 occasions AND duration ≥3 weeks or inpatient fever ≥1 week without diagnosis despite routine evaluation.
- Routine investigations to be done before labelling PUO: Full history & examination, CBC, ESR/CRP, LFTs, RFTs, blood and urine cultures, urinalysis, ANA, RF, chest X-ray, abdominal ultrasound
Exclusion Criteria:
- Pregnancy.
- Known case of immunosuppression
- Contraindication or allergy to iodinated IV contrast (for CECT-CAP arm) that cannot be corrected
- Prior FDG PET/CT or CECT-CAP performed prior to randomization for the current febrile illness that would preclude randomization
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:FDG PET/CT
18F-fluorodeoxyglucose positron emission tomography (FDG-PET)
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whole body 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) scan
Both the group will receive standard care of therapy and Based on diagnostic localisation patient will be subjected to microbiological, histopathological or molecular based testing when amenable to reach final diagnosis.
If assigned investigation didn't provide any diagnostic localization other imaging modality can be used.
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有源比较器:CECT
contrast-enhanced computed tomography (CECT)
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Both the group will receive standard care of therapy and Based on diagnostic localisation patient will be subjected to microbiological, histopathological or molecular based testing when amenable to reach final diagnosis.
If assigned investigation didn't provide any diagnostic localization other imaging modality can be used.
contrast-enhanced computed tomography (CECT) of chest, abdomen and pelvis
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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• Diagnostic localization
大体时间:8 weeks
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Diagnostic localization will be defined as number of participants with any abnormal finding of tracer uptake and/or anatomical variations consistent with clinical suspicion that could not be explained by physiological tracer uptake and/or anatomical variations.
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8 weeks
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Diagnostic yield
大体时间:8 weeks
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Diagnostic yield will be defined as number of participants with diagnostic localization (organ/tissue) which when subjected to microbiological, histopathological and/or molecular based investigation led to a final diagnosis.
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8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time taken for diagnosis
大体时间:8 weeks
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Number of days taken from enrolment to reach final diagnosis
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8 weeks
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Need for additional imaging
大体时间:8 weeks
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Number of participants requiring additional imaging other than primary imaging modality
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8 weeks
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合作者和调查者
调查人员
- 首席研究员:Deba Prasad Dhibar, MD、Post Graduate Institute of Medical Education and Research, Chandigarh, India
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- INT/IEC/2026/SPL-831
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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