NCT06055764

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Oct 2023

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Oct 2023Dec 2026

First Submitted

Initial submission to the registry

September 12, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2.9 years

First QC Date

September 12, 2023

Last Update Submit

September 26, 2023

Conditions

Outcome Measures

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.

    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

Interventions

PET/CTDEVICE

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 21385465BACKGROUND
  • 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.

    PMID: 18925401BACKGROUND

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Esraa Mamdouh

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator of nuclear medicine Assiut university

Study Record Dates

First Submitted

September 12, 2023

First Posted

September 28, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 28, 2023

Record last verified: 2023-09