ClinicalTrials.gg
RecruitingNCT07816783CET-PET-PUOUpdated Oct 5, 2026

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

An interventional study of FDG-PET and CECT in Pyrexia, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2026, registered Sep 2026).
  • Started Apr 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pyrexia

Keywords

  • Pyrexia of unknown origin (PUO)
  • contrast-enhanced computed tomography (CECT)
  • 18F-fluorodeoxyglucose positron emission tomography (FDG-PET)
03

In context

Fever

438 studies on the registry are indexed under Fever; 55 are open to participants now.

This study's planned enrollment of 132 is close to the median of 123 across 271 interventional studies indexed under Fever.

Browse Fever studies →

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 298 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pregnancy.
  • Known case of
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
132 participants (estimated)

Study arms

  • Experimental
    FDG PET/CT

    18F-fluorodeoxyglucose positron emission tomography (FDG-PET)

    Diagnostic Test: FDG-PET · Other: Standard care of therapy

  • Active comparator
    CECT

    contrast-enhanced computed tomography (CECT)

    Diagnostic Test: CECT · Other: Standard care of therapy

Interventions

  • Diagnostic testFDG-PET

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

  • Diagnostic testCECT

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

  • OtherStandard care of therapy

    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.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — All reasonable data requests should be submitted to the principal investigator (DPD) for consideration

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Jun 2027, 14 months after the start.

Of 66 non-industry interventional studies with no phase under Fever, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 14 months is below that.

Counting every sponsor, half of 74 studies reached it within 16 months; a quarter within 6 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2026
First posted
Sep 14, 2026
StartActual
Apr 9, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: description
1 update, last Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07816783
Responsible party
Deba Prasad Dhibar (Principal Investigator, Post Graduate Institute of Medical Education and Research, Chandigarh) — Principal investigator
First posted
Sep 14, 2026
Start date
Apr 9, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Oct 5, 2026

Study contacts

Deba Prasad Dhibar, MD
Contact
drdeba_prasad@yahoo.co.in
+911722756670
Anil Kumar, MBBS
Contact
anilkum13re@gmail.com
+911722756670
Deba Prasad Dhibar, MD
principal investigator · Post Graduate Institute of Medical Education and Research, Chandigarh, India

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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