Cancer Screening for Blood Clots (MVTEP2/SOME2 Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University Hospital, Brest
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing if using a special imaging test called FDG-PET/CT can better detect hidden cancers in patients who have had their first unprovoked blood clot. The test works by using a sugary dye that cancer cells absorb, making them visible on the scan. The goal is to see if this method finds more hidden cancers compared to standard screening.
Is Limited cancer screening + FDG PET/CT a promising treatment for detecting cancer in patients with blood clots?Yes, Limited cancer screening combined with FDG PET/CT is promising because it helps detect hidden cancers in patients with blood clots. It has been effective in identifying different types of cancer, such as thyroid and breast cancer, and can differentiate between cancer-related and non-cancer-related blood clots.34679
What data supports the idea that Cancer Screening for Blood Clots is an effective treatment?The available research shows that using FDG PET/CT for cancer screening in patients with unprovoked blood clots is promising. It has been found to have excellent sensitivity, meaning it is good at detecting cancer when it is present. In one study, FDG PET/CT correctly identified cancer in 80.9% of cases. Additionally, it was able to detect cancer at a stage where it could still be treated effectively. Compared to CT scans alone, FDG PET/CT was more successful in identifying cancerous lesions. This suggests that FDG PET/CT is a useful tool for cancer screening in these patients.167810
What safety data is available for cancer screening using FDG-PET/CT?The safety data for cancer screening using FDG-PET/CT includes a Japanese nationwide survey that evaluated radiation exposure and conducted a risk-benefit analysis. This study aimed to estimate the radiation exposure and assess the risks and benefits associated with FDG-PET in cancer screening.23459
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you have VTE while on anticoagulation medications like apixaban, rivaroxaban, edoxaban, dabigatran, or warfarin, you will be excluded from the study.
Eligibility Criteria
This trial is for people aged 50 or older who have had a blood clot (VTE) without any clear cause. They shouldn't have known clotting disorders, active cancer in the last 5 years, recent major surgery, paralysis, or been bedridden recently. Participants must be able to give consent and commit to follow-up appointments.Inclusion Criteria
I am 50 or older and have a new diagnosis of DVT or PE.
My blood clot was not caused by recent surgery or being bedridden.
My blood clot occurred without any known cause.
My blood clot was not caused by a previous clot.
Exclusion Criteria
I had a blood clot despite being on blood thinners.
Treatment Details
The study is testing two ways of screening for hidden cancers in patients with unexplained blood clots: standard limited cancer screening versus adding a special imaging test called FDG PET/CT that can find cancer.
2Treatment groups
Experimental Treatment
Active Control
Group I: Limited cancer screening + FDG PET/CTExperimental Treatment1 Intervention
Limited screening + FDG PET/CT
Group II: Limited cancer screeningActive Control1 Intervention
Limited screening alone.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Jewish General HospitalMontréal, Canada
McGill University Health CentreMontréal, Canada
Sunnybrook Research InstituteToronto, Canada
University Health NetworkToronto, Canada
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Who is running the clinical trial?
University Hospital, BrestLead Sponsor
Ministry of Health, FranceCollaborator
Canadian Institutes of Health Research (CIHR)Collaborator
Ottawa Hospital Research InstituteCollaborator
References
Application of PET and PEt/CT imaging for cancer screening. [2016]The aim of this study was to evaluate the potential application of 18-fluorodeoxyglucose positron emission tomography (FDG PET) and PET/CT for cancer screening in asymptomatic individuals. The subjects consisted of 3631 physical check-up examinees (1947 men, 1684 women; mean age +/- SD, 52.1 +/- 8.2 y) with non-specific medical histories. Whole-body FDG PET (or PET/CT), ultrasound and tumor markers were performed on all patients. Focal hypermetabolic areas with intensities equal to or exceeding the level of FDG uptake in the brain were considered abnormal and interpreted as neoplasia. Follow-up periods were longer than one year. Among the 3631 FDG PET (including 1687 PET/CT), ultrasound and tumor markers examinations, malignant tumors were discovered in 47 examinees (1.29%). PET findings were true-positive in 38 of the 47 cancers (80.9%). In addition, 32 of the 47 cancers were screened with the PET/CT scan. PET detected cancer lesions in 28 of the 32 examinees. However, the CT detected cancer lesions in only 15 out of 32 examinees. The sensitivity of FDG PET in the detection of a wide variety of cancers is high. Most cancer can be detected with FDG PET at a resectable stage. CT of the PET/CT for localization and characteristics of the lesion showed an increased specificity of the PET scan. The use of ultrasound and tumor markers may complement the PET scan in cancer screening for hepatic and urologic neoplasms.
Radiation exposure and risk-benefit analysis in cancer screening using FDG-PET: results of a Japanese nationwide survey. [2016]The aim of this study was to estimate radiation exposure and evaluate the risks and benefits of 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) in cancer screening.
Detection of thyroid cancer by an FDG-PET cancer screening program: a Japanese nation-wide survey. [2016]The [(18)F]-fluorodeoxyglucose positron emission tomography (FDG-PET) cancer screening program is defined as a cancer screening for asymptomatic subjects using FDG-PET (including PET/ computed tomography [CT]) with or without combination of other screening tests. The aim of the present study was to analyze the thyroid cancer detection rate in asymptomatic individuals through a FDG-PET cancer screening program in Japan.
Detection of breast cancer in an FDG-PET cancer screening program: results of a nationwide Japanese survey. [2016]The [18F]-fluorodeoxyglucose positron emission tomography (FDG-PET) cancer screening program is defined as cancer screening for asymptomatic subjects using FDG-PET/computed tomography with or without combination of other screening tests. The aim of this study was to analyze the detection rate and effectiveness of the FDG-PET cancer screening program for breast cancer between 2006 and 2009 in Japan.
Sensitivity of 2-[18F]fluoro-2-deoxyglucose positron emission tomography for advanced colorectal neoplasms: a large-scale analysis of 7505 asymptomatic screening individuals. [2019]Label="BACKGROUND" NlmCategory="BACKGROUND">The sensitivity of 2-[18F]fluoro-2-deoxyglucose positron emission tomography (FDG-PET) for advanced colorectal neoplasms among healthy subjects is not yet fully understood. The present study aimed to clarify the sensitivity by analyzing large-scale data from an asymptomatic screening population.
Rare case of an ovarian vein tumor thrombosis identified on fluorodeoxyglucose positron emission tomography/computed tomography. [2020]Fludeoxyglucose positron emission tomography/computed tomography is valuable in the identification of tumor thrombus and differentiating it from bland thrombus which has implications in initiating anticoagulation. We present a rare case of tumor thrombosis in ovarian vein, in a recurrent case of uterine carcinosarcoma.
Performance of 18F-fluorodesoxyglucose positron-emission tomography combined with low-dose computed tomography for cancer screening in patients with unprovoked venous thromboembolism. [2018]Small series have suggested that Fluorodesoxyglucose Positron-Emission-Tomography with Computed-Tomography (FDG-PET/CT) is feasible to screen for cancer in patients with unprovoked venous thromboembolism (VTE), but without validation in a large population. The aim was to assess diagnostic accuracy indices of FDG-PET/CT for occult cancer diagnosis in patients with unprovoked VTE.
Utility of FDG PET/CT for assessment of lung nodules identified during low dose computed tomography screening. [2021]Many clinical guidelines recommend FDG PET/CT for the evaluation of pulmonary nodules ≥8 mm detected during low dose computed tomography (LDCT) lung cancer screening. However, its added value in this setting requires confirmation. We evaluated the clinical utility of FDG PET/CT, including incidental findings, during the evaluation of lung nodules detected on LDCT screening.
Performance of 18F-fluorodesoxyglucose positron-emission tomography/computed tomography for cancer screening in patients with unprovoked venous thromboembolism: Results from an individual patient data meta-analysis. [2021]Label="INTRODUCTION">Venous thromboembolism (VTE) may be the first manifestation of cancer. We aimed at evaluating the performance of 18F-Fluorodesoxyglucose Positron-Emission Tomography/Computed Tomography (FDG PET/CT) for occult cancer screening in patients with unprovoked VTE.
18F-Fluorodeoxyglucose positron emission/computed tomography for occult cancer among patients with unprovoked venous thromboembolism: What do we know? [2022]18F-Fluorodeoxyglucose Positron Emission/Computed Tomography (FDG PET/CT) is a non-invasive whole-body imaging modality that has the potential for replacing multiple cancer screening tests by one. Previous studies showed that FDG PET/CT has an excellent sensitivity and negative predictive value for occult cancer screening in patients with unprovoked venous thromboembolism (VTE). In this patient population, FDG PET/CT is a reproducible imaging procedure with a kappa value estimated at 0.75. Although false positive results may lead to unnecessary investigations, it seems from recent evidence that invasive procedures triggered by a positive scan often resulted in cancer diagnosis. Trials assessing use of FDG PET/CT for occult cancer screening in patients with VTE at high risk for occult cancer diagnosis are ongoing.