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NCT Number: NCT06055764

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

Evaluatation of the role of F18FDG-PET/CT in patients with metastases of unknown origin.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET/CT

Device

Patient preparation: Patients will fast for 4 - 6 h before PET scanning to optimize the blood sugar level to 160mg/dl. F-18 FDG dose was 0.14 mCi/kg and injected via intravenous route. During the uptake phase of 18F-FDG patients will be rested in a quite warm room.

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa Mamdouh

CONTACT

[email protected]

+20112322029

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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