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Distant MetastasisNCT06205901

Comparison Study Between PET/CT and Whole-Body Diffusion Weighted MRI in the Detection of Distant Malignancies

An observational study of Distant Metastasis, run by Sohag University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Distant Metastasis
What is being tested?
PET-CT, MRI
Type of treatment
Medical device
How many people
50 participants
Where
No sites listed yet
Study dates
1 Mar 2024to 1 Apr 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • • 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.

About this study

Official title: 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

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.

Read the 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.

WB-MRI primarily provides structural information (revealing a detailed image of the pathology or lesion) on tumor spread; however, the absence of functional datasets has been resolved by incorporating Whole-body Diffusion Weighted Imaging (WB-DWI) into medical practice. WB-DWI shortens examination interpretation times by directing the radiologist's attention to abnormalities, which may then be investigated on anatomic sequences. It enables early detection of skeletal metastases as well as spread to other sites (liver and brain).

DW-MRI measures the Brownian motion of water molecules within intra- and extracellular spaces. This occurs in highly cellular lesions or in environments in which tissue architecture is disrupted and can be quantified by calculating the apparent diffusion coefficient (ADC).

Being tested
PET-CT, MRI
Keywords
PET-CT, WB-MRI, Cancer patients, Distant metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET-CT, MRIDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 Year

Secondary outcomes (4)

  1. DWI-MRI in detection of metastatic lesions in cancer patients

    detection of malignancy with applying ADC cut-off level for differentiating the malignant metastatic deposits.

    qualitative interpretation: differentiation of benign from malignant lesions can be determined through presence Vs absence diffusion restriction at diffusion weighted images (DWI), as only the malignant lesions that show diffusion restriction .

    quantitative interpretation: 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.

    Measured: 1 Year

  2. MRI in detection of metastatic lesions in cancer patients

    comparing each sequence of MRI in different organs including T2WI, T1WI and DWI sequences. ? Which is the best for detection and characterization of the Metastatic lesions in different bony and soft tissue in different parts of the body.

    T2WI \& T1WI are descriptive names of sequences in the MRI study that can be evaluated qualitatively.

    DWI is a descriptive name of sequences in the MRI study that can be evaluated qualitatively and quantitively through using the ADC value which is a descriptive name of the measure of the magnitude of diffusion (of water molecules) within tissue.

    Measured: 1 Year

  3. Added value PET-CT in detection of metastatic lesions in cancer patients

    value of PET CT in detection of malignant metastatic deposits in bony and soft tissue lesions and the different pitfalls including the inflammatory conditions. Does the PET-CT can overcome it and how much sensitivity it has? qualitative interpretation : differentiation of benign from malignant lesions can be determined through the degree of 16F-FGD uptake as malignant lesions show avid uptake.

    quantitative interpretation: 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, that is more than 2.0 is considered to be suggestive of malignancy, whereas lesions with SUVs less than this value are considered to be benign.

    Measured: 1 Year

  4. Accuracy of SUV value in PET-CT for detection of metastatic lesions in cancer patients

    detection of malignancy by applying Cut-Off level SUV value in detection and differentiation of metastatic deposits.

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2024
  2. Study start1 Mar 2024 (estimated)
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06205901
Sponsor's protocol ID
PET-CT and MRI in malignancy
Status last verified
Jan 2024
First submitted
4 Jan 2024
Last updated
18 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37503694

  • 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.

    PubMed 36925744

  • 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.

    PubMed 37029988

  • 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.

    PubMed 33350173

Questions about this trial

What is this clinical trial studying?

An observational study of Distant Metastasis, run by Sohag University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06205901, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.

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