PyrexiaCET-PET-PUONCT07816783
Comparison of FDG-PET/CT and CECT-CAP as Upfront Imaging Modality for the Diagnosis of Pyrexia of Unknown Origin
A study testing FDG-PET and CECT in people with Pyrexia, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pyrexia
- What is being tested?
- FDG-PET and CECT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteIndia
- Study dates
- 9 Apr 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Medical Education and Research, Chandigarh, India
Chandigarh, Chandigarh, 160012
Deba Prasad Dhibar, MD, +911722756670, drdeba_prasad@yahoo.co.in
Anil Kumar, MBBS, +911722756670, anilkum13re@gmail.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Pyrexia
- Being tested
- FDG-PET, CECT, Standard care of therapy
- Keywords
- Pyrexia of unknown origin (PUO), contrast-enhanced computed tomography (CECT), 18F-fluorodeoxyglucose positron emission tomography (FDG-PET)
- Medical subject headings
- Fever, Fever of Unknown Origin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PETDiagnostic test
whole body 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) scan
CECTDiagnostic test
contrast-enhanced computed tomography (CECT) of chest, abdomen and pelvis
Standard care of therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| FDG PET/CT | Experimental | 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) Receives: Diagnostic Test: FDG-PET; Other: Standard care of therapy |
| CECT | Active comparator | contrast-enhanced computed tomography (CECT) Receives: Diagnostic Test: CECT; Other: Standard care of therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: 8 weeks
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.
Measured: 8 weeks
Secondary outcomes (2)
Time taken for diagnosis
Number of days taken from enrolment to reach final diagnosis
Measured: 8 weeks
Need for additional imaging
Number of participants requiring additional imaging other than primary imaging modality
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start9 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PyrexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deba Prasad Dhibar, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Deba Prasad Dhibar, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816783
- Sponsor's protocol ID
- INT/IEC/2026/SPL-831
- Acronym
- CET-PET-PUO
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All reasonable data requests should be submitted to the principal investigator (DPD) for consideration
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of FDG-PET/CT and CECT-CAP as Upfront Imaging Modality for the Diagnosis of Pyrexia of Unknown Origin : A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07816783
- Acronym / sponsor ID
- CET-PET-PUO / INT/IEC/2026/SPL-831
- Conditions
- Pyrexia
- Keywords
- Pyrexia of unknown origin (PUO), contrast-enhanced computed tomography (CECT), 18F-fluorodeoxyglucose positron emission tomography (FDG-PET)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FDG PET/CT | Experimental | Diagnostic Test: FDG-PET, Other: Standard care of therapy18F-fluorodeoxyglucose positron emission tomography (FDG-PET) |
| CECT | Active comparator | Diagnostic Test: CECT, Other: Standard care of therapycontrast-enhanced computed tomography (CECT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG-PETwhole body 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) scan | Diagnostic test | FDG PET/CT |
| CECTcontrast-enhanced computed tomography (CECT) of chest, abdomen and pelvis | Diagnostic test | CECT |
| Standard care of therapyBoth 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. | Other | CECT, FDG PET/CT |
Primary outcome
• Diagnostic localization
Time frame: 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.
Diagnostic yield
Time frame: 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.
2 secondary outcomes
Time taken for diagnosis
Time frame: 8 weeks
Need for additional imaging
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. All reasonable data requests should be submitted to the principal investigator (DPD) for consideration
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deba Prasad Dhibar, MD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG-PET and CECT in people with Pyrexia, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deba Prasad Dhibar, MD (+911722756670, drdeba_prasad@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Diagnostic localization (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.