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Abdominal Sepsis18F-FDG PET/CTNCT07127627

Characterization of Abdomino-pelvic Lesions by 18Fluorine- Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography

An observational study of Abdominal Sepsis, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The aim of the study is to identify and characterize lesions in the abdominopelvic region detected by 18fluorine- fluorodeoxyglucose (FDG) positron Emission Tomography combined Computed Tomography (PET/CT) scan, including determining their malignant or benign nature, and to determine the extent of disease to… Read more about this study

Who is it for?
Any age
Conditions the study is for
Abdominal Sepsis
What is being tested?
PET/CT
Type of treatment
Medical device
How many people
79 participants
Where
No sites listed yet
Study dates
Aug 2025to Nov 2028
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: patients were suspected of having malignancy (new, recurrent or metastatic) based on pathology or conventional radiological studies and were referred to nuclear medicine unit for 18F-FDG-PET-CT scan

Who may be able to join

  • Inclusion criteria: All of the patients were suspected of having malignancy (new, recurrent or metastatic) based on pathology or conventional radiological studies and were referred to nuclear medicine unit for 18F-FDG-PET-CT scan

Who cannot join

  • patients underwent recent abdominal or pelvic surgery.
  • patients with blood glucose level ˃200 mg/dL
  • Pregnancy

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

salma A samy, ass. lecturer contact

01069720261

salmasamy95@aun.edu.eg

waleed A diab, ass. prof contact

01004242213

Waleed.diab@aun.edu.eg

About this study

Official title: Characterization of Abdomino-pelvic Lesions in Cancer Patients by 18F-FDG PET/CT

The aim of the study is to identify and characterize lesions in the abdominopelvic region detected by 18fluorine- fluorodeoxyglucose (FDG) positron Emission Tomography combined Computed Tomography (PET/CT) scan, including determining their malignant or benign nature, and to determine the extent of disease to facilitate proper management

Read the detailed description

positron Emission Tomography combined Computed Tomography is a hybrid imaging that provides both anatomical and functional data that helps to differentiate between benign and malignant diseases. [18F]FDG is taken up by both normal cells utilizing glucose like (kidneys, ureters and urinary bladder due to urinary excretion, Variable degrees of uptake can also seen in the liver, spleen, bone marrow, bowel, testes and uterus) .and also the tumor cells which usually have a high glucose demand. This uptake is mediated by the cell surface carrier molecules designated as glucose transporters (GLUT) and can be measured with the semi quantitative index called standardized uptake values (SUV) Cancer cells divide rapidly and have greater metabolic rates. Through the upregulation of glucose transport proteins on the cell membrane, cancer cells exhibit enhanced glucose uptake . Studies have demonstrated that SUV of 2.5 can differentiate malignant versus benign tissues , thus, Proper characterization of abdomino-pelvic lesions will lead to improve chances for successful management and treatment.

Multiple studies have shown that Dual-time point (DTP) 18F-FDG PET/CT may provide more help in the differentiation of malignant lesions from benign ones.as Dual-Time-Point PET/CT involves two scans, one early and one delayed, allowing for the assessment of FDG uptake kinetics, malignant tumors tend to show increased FDG uptake over time, indicating higher glucose metabolism. But benign Lesions or those with inflammatory processes may show a decrease or no significant change in FDG uptake over time.

FDG activity in urine interferes with tumor activity. Therefore, the value of FDG PET has only a limited role in detecting tumors in the bladder wall and urinary tract, Thus several methods have been investigated and tested to reduce urine FDG activity: catheterization, dual-phase imaging, early PET images, late PET images after voiding, oral hydration, and forced diuresis

Being tested
PET/CT
Keywords
abdominopelvic lesions
Medical subject headings
Intraabdominal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET/CTDevice

    positron emission tomography/computed tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the performance of 18F FDG PET/CT

    identify and characterize abdominopelvic lesions, initial staging, follow up of treatment and detection of recurrence in the abdominopelvic region, including determining their malignant or benign nature, and to determine the extent of disease, Assess the spread of disease to lymph nodes, distant metastases, or other areas, to facilitate proper management.

    Measured: 3 years

Secondary outcomes (1)

  1. Evaluate the diagnostic power of alternative technologies

    Evaluate the diagnostic power of alternative technologies like dual time point images, bladder evacuation and forced diuresis in characterizing abdominopelvic lesions.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2025
  2. Study startAug 2025 (estimated)
  3. Primary completionOct 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
79 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07127627
Sponsor's protocol ID
characterization by PET/CT
Acronym
18F-FDG PET/CT
Status last verified
Aug 2025
First submitted
9 Aug 2025
Last updated
17 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bouchelouche K. PET/CT in Bladder Cancer: An Update. Semin Nucl Med. 2022 Jul;52(4):475-485. doi: 10.1053/j.semnuclmed.2021.12.004. Epub 2022 Jan 5.

    PubMed 34996595

  • Khandelwal Y, Singh Parihar A, Sistani G, Ramirez-Fort MK, Zukotynski K, Subramaniam RM. Role of PET/Computed Tomography in Gastric and Colorectal Malignancies. PET Clin. 2024 Apr;19(2):177-186. doi: 10.1016/j.cpet.2023.12.004. Epub 2024 Jan 9.

    PubMed 38199915

  • Wang J, Liu X. Medical image recognition and segmentation of pathological slices of gastric cancer based on Deeplab v3+ neural network. Comput Methods Programs Biomed. 2021 Aug;207:106210. doi: 10.1016/j.cmpb.2021.106210. Epub 2021 May 29.

    PubMed 34130088

  • Sartin SL, Shetty DR, Strange CD, Gayer G, Ahuja J, Agrawal R, Truong MT. Pitfalls in Positron Emission Tomography/Computed Tomography in the Thorax and Abdomen. Semin Ultrasound CT MR. 2024 Dec;45(6):488-495. doi: 10.1053/j.sult.2024.07.012. Epub 2024 Jul 26.

    PubMed 39069275

  • Cao Y, Zhou K, Diao W, Long X, Tian F, Su M, Jia Z. Age-related changes of standardized uptake values in the blood pool and liver: a decade-long retrospective study of the outcomes of 2,526 subjects. Quant Imaging Med Surg. 2021 Jan;11(1):95-106. doi: 10.21037/qims-20-35.

    PubMed 33392014

Questions about this trial

What is this clinical trial studying?

An observational study of Abdominal Sepsis, run by Assiut University.

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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

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 salma A samy, ass. lecturer (01069720261, salmasamy95@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the performance of 18F FDG PET/CT (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07127627, which also lists 5 linked publications.

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 17 Aug 2025.

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