NCT06205901

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Status
unknown

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

First Submitted

Initial submission to the registry

January 4, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

January 4, 2024

Last Update Submit

January 14, 2024

Conditions

Keywords

PET-CT, WB-MRI, Cancer patients, Distant metastasis

Outcome Measures

Primary Outcomes (1)

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

    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.

    1 Year

Secondary Outcomes (4)

  • 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

Interventions

whole body MRI and PET-CT for cancer patients with distant metastasis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult patient, having present history of malignancy and referred from the general surgery or oncology clinics as having known metastatic lesions proven by histopathology or cytology. all Patients should be eligible to go through both modalities; PET-CT and MRI.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Feng Y, Wang P, Chen Y, Dai W. 18 F-FDG PET/CT for evaluation of metastases in nonsmall cell lung cancer on the efficacy of immunotherapy. Nucl Med Commun. 2023 Oct 1;44(10):900-909. doi: 10.1097/MNM.0000000000001737. Epub 2023 Jul 31.

    PMID: 37503694BACKGROUND
  • Rashid RJ, Tahir SH, Kakamad FH, Omar SS, Salih AM, Ahmed SF, Abdalla SH, Naqar S, Salih RQ, Kakamad SH, Mohammed KK, Mustafa SM, Hassan MN, Mohammed SH. Whole-body MRI for metastatic workup in patients diagnosed with cancer. Mol Clin Oncol. 2023 Mar 1;18(4):33. doi: 10.3892/mco.2023.2629. eCollection 2023 Apr.

    PMID: 36925744BACKGROUND
  • Cristo Santos J, Henriques Abreu M, Seoane Santos M, Duarte H, Alpoim T, Prospero I, Sousa S, Henriques Abreu P. Bone Metastases Detection in Patients with Breast Cancer: Does Bone Scintigraphy Add Information to PET/CT? Oncologist. 2023 Aug 3;28(8):e600-e605. doi: 10.1093/oncolo/oyad087.

    PMID: 37029988BACKGROUND
  • Chen J, Wu L, Zhang Z, Zheng S, Lin Y, Ding N, Sun J, Shi L, Xue M. A clinical model to predict distant metastasis in patients with superficial gastric cancer with negative lymph node metastasis and a survival analysis for patients with metastasis. Cancer Med. 2021 Feb;10(3):944-955. doi: 10.1002/cam4.3680. Epub 2020 Dec 22.

Related Links

MeSH Terms

Interventions

Positron Emission Tomography Computed Tomography

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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer, Radiology department

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 16, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

January 18, 2024

Record last verified: 2024-01