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

8 september 2026 bijgewerkt door: Deba Prasad Dhibar, Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Geschat)

132

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • Chandigarh
      • Chandigarh, Chandigarh, Indië, 160012
        • Werving
        • Post Graduate Institute of Medical Education and Research, Chandigarh, India
        • Hoofdonderzoeker:
          • Deba Prasad Dhibar, MD
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: FDG PET/CT
18F-fluorodeoxyglucose positron emission tomography (FDG-PET)
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.
Actieve vergelijker: CECT
contrast-enhanced computed tomography (CECT)
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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
• Diagnostic localization
Tijdsspanne: 8 weeks
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.
8 weeks
Diagnostic yield
Tijdsspanne: 8 weeks
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.
8 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time taken for diagnosis
Tijdsspanne: 8 weeks
Number of days taken from enrolment to reach final diagnosis
8 weeks
Need for additional imaging
Tijdsspanne: 8 weeks
Number of participants requiring additional imaging other than primary imaging modality
8 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Deba Prasad Dhibar, MD, Post Graduate Institute of Medical Education and Research, Chandigarh, India

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

9 april 2026

Primaire voltooiing (Geschat)

30 juni 2027

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

8 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 september 2026

Eerst geplaatst (Werkelijk)

14 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 september 2026

Laatste update ingediend die voldeed aan QC-criteria

8 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

All reasonable data requests should be submitted to the principal investigator (DPD) for consideration

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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