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

Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06055764
• Other study ID #: PET/CT in MUO
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: December 2026

Study information

• Verified date: September 2023
• Source: Assiut University
• Contact: Esraa Mamdouh
• Phone: +20112322029
• Email: esraamamdouh22222[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 73
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastasis
• Neoplasm Metastasis

Intervention

Device:
• PET/CT
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Kwee TC, Kwee RM. Combined FDG-PET/CT for the detection of unknown primary tumors: systematic review and meta-analysis. Eur Radiol. 2009 Mar;19(3):731-44. doi: 10.1007/s00330-008-1194-4. Epub 2008 Oct 17. — View Citation

Park JS, Yim JJ, Kang WJ, Chung JK, Yoo CG, Kim YW, Han SK, Shim YS, Lee SM. Detection of primary sites in unknown primary tumors using FDG-PET or FDG-PET/CT. BMC Res Notes. 2011 Mar 9;4:56. doi: 10.1186/1756-0500-4-56. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Role of FDG PET/CT in patients with metastasis of unknown origin. Role of FDG PET/CT in patients with metastasis of unknown origin.	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