Role of FDG PET/CT in Patients With Metastasis of Unknown Origin

September 26, 2023 updated by: Esraa Mamdouh, Assiut University
Evaluatation of the role of F18FDG-PET/CT in patients with metastases of unknown origin.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cancer of unknown primary origin (CUP) includes a cluster of heterogeneous tumors that have exceptional clinical features: it is defined as early apparent metastatic disease with no recognizable primary site at the time of presentation. The incidence of CUP ranges around 2% of all new cancer diagnoses.

The work up list of CUP include; a biopsy proven malignancy, a detailed physical examination, many laboratory, radiological and endoscopy. However, these investigations may be costly time-consuming and may eventually fail to detect the site of the primary malignant tumor in the majority of patients. In this context, positron-emission tomography (PET) combined with computed tomography (PET/CT), using the radiotracer 18F fluoro- 2-deoxyglucose (FDG) is an alternative, non-invasive imaging modality with accurate diagnostic performance. It considered good tool for diagnosis of patients with CUP . The basis for use of FDG as radiotracer for PET imaging in CUP depends on the fact that most of the malignant cancer phenotypes show an increased glucose metabolism rate.

Failure to identify the primary tumor hampers optimization of management planning, which in turn may adversely influence patient prognosis.

Study Type

Observational

Enrollment (Estimated)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

This study will recruit patients with suspected or proven MUO referred to the nuclear medicine unit to detect primary site.

Description

Inclusion Criteria:

  • Patients with age more than 18 years presented with either pathologically proved metastases of unknown primary or
  • Patients with clinico-radiological suspicious of having metastases.

Exclusion Criteria:

  • • Age below 18 years,

    • patients with pathologically proved primary tumor,
    • Patients suffering from advanced disease and in-cooperative patients.
    • Pregnant and lactating women.
    • Patients who had motion artifacts, or those who can't stay stable or calm during acquisition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of FDG PET/CT in patients with metastasis of unknown origin. Role of FDG PET/CT in patients with metastasis of unknown origin.
Time Frame: through study completion an average 2 years

patients with metastasis of unknown origin will do PET/CT searching for primary and find if it will change management or not

Procedure:

All PET-CT studies will be done at the nuclear medicine unit in Assuit University Hospital.

PET-CT images will be interpreted at a workstation equipped with fusion software that offers multi-planar reformatted images and enables display of the PET images, CT images, and fused PET/CT images.
through study completion an average 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Esraa Mamdouh, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PET/CT in MUO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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