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Clinical Trials/NCT06205901
NCT06205901Not yet recruitingNot Applicable

A Prospective Comparison Study Between 18F-FDG PET/CT and Whole-Body Diffusion Weighted MRI in the Detection of Distant Malignancies in Patients With Various Cancers

Sohag University0 sites50 target enrollmentStarted: March 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
50
Primary Endpoint
comparison between the efficacy of 18F-FDG PET/CT and DWI WB-MRI in detection of distant metastasis of various cancers

Study Overview

Brief Summary

The purpose of the study is to compare the efficacy of 18F-FDG PET/CT and DWI WB-MRI in detection of distant metastasis of various cancers.

Detailed Description

Metastasis is the leading cause of morbidity and mortality in patients with cancer, accounting for ~90% of cancer-associated deaths.

Distant metastasis (DM) is a crucial point in the management of malignant tumors. DM is always associated with poor survival. Conclusive diagnosis of DM is crucial for improving the prognosis, reduction of the recurrence rate and hence, elevation of the 5-year survival rate.

Positron emission tomography/computed tomography (PET/CT) allows the analysis of active tumor tissue in the whole body. So, it obtains improved sensitivity and specificity when compared to conventional imaging modalities.

18F-FDG PET/CT is a diagnostic imaging modality with good quantitative properties. It has proven its interest in diagnosing, staging, and evaluating tumor response.

Whole-body MRI (WB-MRI) has been proposed as another effective whole-body approach for assessing both local invasiveness and distant metastases in patients with newly diagnosed cancers providing several advantages.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Only patients with malignancies proven by histology and patients with metastatic lesions proven by histopathology or cytology were included.

Exclusion Criteria

  • • As regard the PET/CT study, patients who have the general CT contraindications such as pregnancy, breast feeding, history of allergic reaction to the contrast medium, renal disease, etc.
  • As regard the MRI study, general contraindications including claustrophobia, MR-incompatible pacemakers and MR-incompatible heart valves.
  • Patients whose MRI sequences were incomplete, low-quality and/or had no histopathological evidence of metastatic lesions were eliminated from the study.
  • Low-quality or incomplete MRI included MRI exams with incomplete sequence(s), which is particularly common in elderly patients who are unable to tolerate the scan, or uncooperative patients who do not obey breathing instructions and motion artifacts that may impair images and lead to lower accuracy.
  • Declined consent.

Outcomes

Primary Outcomes

comparison between the efficacy of 18F-FDG PET/CT and DWI WB-MRI in detection of distant metastasis of various cancers

Time Frame: 1 Year

comparing the value of both PET-CT and whole body MRI mainly the DWI sequence in detection of bony and soft tissue metastasis in different types of malignancy. Which? will be better in early detection. PET-CT: differentiation of benign from malignant lesions can be determined using (Standardized uptake value) (SUV) as malignant lesions show higher SUV than benign lesions. Typically, a standardized uptake value (SUV) is a descriptive name of the quantity that incorporates the patient's size and the injected dose; \> 2.0: considered malignancy, less than this value: considered to be benign. DWI WB-MRI: differentiation of benign from malignant lesions can be determined using ADC value as malignant lesions show low ADC value compared to the benign lesions. Apparent diffusion coefficient (ADC) is a descriptive name of the measure of the magnitude of diffusion (of water molecules) within tissue.

Secondary Outcomes

  • DWI-MRI in detection of metastatic lesions in cancer patients(1 Year)
  • MRI in detection of metastatic lesions in cancer patients(1 Year)
  • Added value PET-CT in detection of metastatic lesions in cancer patients(1 Year)
  • Accuracy of SUV value in PET-CT for detection of metastatic lesions in cancer patients(1 Year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hala Mohamed Ahmed

Assistant lecturer, Radiology department

Sohag University

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