Comparison of FDG-PET/CT and CECT-CAP as Upfront Imaging Modality for the Diagnosis of Pyrexia of Unknown Origin

ConditionPyrexia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

About this trial

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 investigators will evaluate and compare the diagnostic localization and diagnostic yield of FDG PET/CT over CECT-CAP for etiological diagnosis of PUO.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • FDG-PET

    Diagnostic test

    whole body 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) scan

  • CECT

    Diagnostic test

    contrast-enhanced computed tomography (CECT) of chest, abdomen and pelvis

  • Standard care of therapy

    Other intervention

    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.

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: FDG PET/CTExperimental treatment 2 interventions
Group B: CECTActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

• Diagnostic localization

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.

Time frame
8 weeks
2

Diagnostic yield

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.

Time frame
8 weeks

Secondary outcomes

1

Time taken for diagnosis

Number of days taken from enrolment to reach final diagnosis

Time frame
8 weeks
2

Need for additional imaging

Number of participants requiring additional imaging other than primary imaging modality

Time frame
8 weeks

Other outcomes

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