Cancer Screening for Blood Clots

(MVTEP2/SOME2 Trial)

Recruiting at 21 trial locations

Overseen By Pierre-Yves SALAUN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospital, Brest

Must not be taking: Anticoagulants

Disqualifiers: Active malignancy, Recent paralysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1276 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to detect hidden cancers in individuals who have recently experienced an unprovoked blood clot in their legs or lungs. The researchers will compare two methods: basic cancer screening and a more detailed screening using FDG PET/CT scans, a special imaging technique that shows cellular activity. The goal is to determine if these screenings can catch cancers early in cases of unexplained blood clots. Individuals aged 50 or older who have had their first unprovoked blood clot may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance early cancer detection methods.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulation (blood thinners), you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that FDG PET/CT scans for cancer screening are generally safe and well-tolerated by patients. In a pilot study, these scans were performed without major safety issues. The study found unusual results in about 62.5% of patients, sometimes requiring additional tests. This indicates that the scans are effective at identifying potential problems, without causing serious side effects during the study.

FDG PET/CT scans excel at detecting hidden cancers, with a sensitivity of 88.7%, meaning they correctly identify 88.7% of people with cancer. They also have a specificity of 80.9%, meaning they correctly identify 80.9% of people without cancer, with few false positives.

Overall, the scans seem to be a safe and effective tool for cancer screening in patients with blood clots. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to screen for blood clots in cancer patients. Unlike standard imaging tests, the addition of FDG PET/CT to limited cancer screening could offer more detailed insights. This advanced imaging technique uses a special dye and camera to look at organs and tissues, potentially detecting issues earlier and more accurately. By combining these methods, researchers hope to improve the early detection of blood clots, which can be critical in managing cancer care effectively.

What evidence suggests that this trial's treatments could be effective for identifying occult cancers in patients with unprovoked VTE?

Research has shown that using FDG PET/CT scans in cancer screening for individuals with unexplained blood clots (VTE) can improve health outcomes. In this trial, participants will join different groups: one will undergo limited cancer screening alone, while another will receive limited cancer screening combined with FDG PET/CT. Studies indicate that the FDG PET/CT method detects cancer in 70% of patients who test positive, while only 0.7% of those who test negative are later found to have cancer. This demonstrates that FDG PET/CT is highly effective at identifying hidden cancers early. Evidence also suggests that this technique reduces the risk of late cancer diagnosis and enhances quality of life, making it a promising option for individuals over 50 with unexplained blood clots. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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

My blood clot was not caused by cancer or any known risk factors.

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.

Exclusion Criteria

Unavailable to follow-up

Refusal or inability to provide informed consent

You are allergic to 18F-FDG or any of the ingredients in the product.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Cancer Screening

Participants undergo limited cancer screening or limited screening plus FDG PET/CT

1 month

Follow-up

Participants are monitored for missed occult cancers and other outcomes

1 year

Extended Follow-up

Participants are monitored for cancer-related mortality and other long-term outcomes

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Limited cancer screening
• Limited cancer screening + FDG PET/CT

Trial Overview 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.

How Is the Trial Designed?

Group I: Limited cancer screening + FDG PET/CT Experimental Treatment 1 Intervention

Limited screening + FDG PET/CT

Group II: Limited cancer screening Active Control 1 Intervention

Limited screening alone.

Who Is Running the Clinical Trial?

University Hospital, Brest

Lead Sponsor

Trials

597

Recruited

257,000+

Ministry of Health, France

Collaborator

Trials

383

Recruited

722,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Ottawa Hospital Research Institute

Collaborator

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

Fludeoxyglucose PET/CT is effective in distinguishing between tumor thrombus and bland thrombus, which is crucial for deciding on anticoagulation treatment.

The case presented involves a rare occurrence of tumor thrombosis in the ovarian vein associated with recurrent uterine carcinosarcoma, highlighting the importance of advanced imaging in identifying such complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rare case of an ovarian vein tumor thrombosis identified on fluorodeoxyglucose positron emission tomography/computed tomography. Chandra, P., Agrawal, A., Purandare, N., et al.[2020]

In a study involving 153,775 asymptomatic individuals, the FDG-PET cancer screening program successfully detected thyroid cancer in 353 cases, demonstrating a high sensitivity of 90.7%, comparable to thyroid ultrasonography.

Combining FDG-PET with thyroid ultrasonography improved detection rates, indicating that this approach could enhance early-stage thyroid cancer diagnosis, with most detected cases being at UICC stage I.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of thyroid cancer by an FDG-PET cancer screening program: a Japanese nation-wide survey. Minamimoto, R., Senda, M., Jinnouchi, S., et al.[2016]

In a study of 172 patients with unprovoked venous thromboembolism (VTE), FDG-PET/CT demonstrated good diagnostic accuracy for detecting occult cancer, with a sensitivity of 90% and specificity of 85% when considering positive and equivocal results together.

The method identified malignancy in 70% of patients with positive results and only 0.7% in those with negative results, indicating its potential effectiveness in cancer screening for this specific patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of 18F-fluorodesoxyglucose positron-emission tomography combined with low-dose computed tomography for cancer screening in patients with unprovoked venous thromboembolism. Robin, P., Le Roux, PY., Lacut, K., et al.[2018]

In a study of 7505 asymptomatic individuals, FDG-PET demonstrated a low sensitivity of only 16.9% for detecting advanced colorectal neoplasms, indicating it may not be effective as a primary screening tool.

Despite its high specificity (99.3%) and negative predictive value (99.4%), the low sensitivity, particularly for smaller, less advanced, and flat lesions, suggests that FDG-PET should be used cautiously in colorectal cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity of 2-[18F]fluoro-2-deoxyglucose positron emission tomography for advanced colorectal neoplasms: a large-scale analysis of 7505 asymptomatic screening individuals. Sekiguchi, M., Kakugawa, Y., Terauchi, T., et al.[2019]

The FDG-PET cancer screening program effectively detected breast cancer in asymptomatic women, identifying 161 cases out of 473 possible cases, with a relative sensitivity of 83.9%.

Combining FDG-PET with mammography and breast ultrasonography improved detection sensitivity, particularly for early-stage cancers (83.0% detected were stage 0 or I), but did not enhance the positive predictive value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of breast cancer in an FDG-PET cancer screening program: results of a nationwide Japanese survey. Minamimoto, R., Senda, M., Jinnouchi, S., et al.[2016]

In a study of 332 patients with unprovoked venous thromboembolism (VTE), FDG PET/CT demonstrated a high negative predictive value of 98.9%, making it effective for ruling out occult cancer.

The test showed a pooled sensitivity of 87.3% and specificity of 70.2%, indicating that while it is good at detecting cancer, there is still a chance of false positives, as evidenced by a low positive predictive value of 17.9%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Robin, P., van Es, N., Le Roux, PY., et al.[2021]

The average radiation exposure from FDG-PET scans is estimated at 4.4 mSv for dedicated PET and 13.5 mSv for PET/CT, which is higher than typical X-ray tests, indicating a need for careful consideration of risks.

The study found that FDG-PET cancer screening is beneficial for individuals above certain break-even ages: in the 40s for men and 30s for women for dedicated PET, and in the 50s for both genders for PET/CT, suggesting that the benefits of screening outweigh the risks of radiation exposure in these age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation exposure and risk-benefit analysis in cancer screening using FDG-PET: results of a Japanese nationwide survey. Murano, T., Minamimoto, R., Senda, M., et al.[2016]

In a study of 75 patients with lung nodules detected during LDCT screening, FDG PET/CT helped determine management strategies, with 50.6% of nodules deemed benign leading to non-invasive follow-up, while 49.3% were indeterminate or suggested malignancy, prompting biopsies in 86% of those cases.

FDG PET/CT also revealed incidental findings in 49% of patients, with 28% requiring further investigation, highlighting the importance of this imaging technique in both evaluating lung nodules and uncovering additional health concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of FDG PET/CT for assessment of lung nodules identified during low dose computed tomography screening. Hadique, S., Jain, P., Hadi, Y., et al.[2021]

In a study of 3631 asymptomatic individuals, FDG PET and PET/CT demonstrated a high sensitivity for detecting malignant tumors, identifying 80.9% of cancers found during screening.

PET/CT scans were more effective than CT alone, detecting cancer lesions in 28 out of 32 cases, while the CT component only identified 15, highlighting the importance of PET in early cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of PET and PEt/CT imaging for cancer screening. Chen, YK., Ding, HJ., Su, CT., et al.[2016]

FDG PET/CT is a promising non-invasive imaging technique that could potentially replace multiple cancer screening tests, showing excellent sensitivity and negative predictive value for detecting hidden cancers in patients with unprovoked venous thromboembolism (VTE).

The procedure is reproducible with a high reliability (kappa value of 0.75), and while false positives can lead to unnecessary follow-ups, they often result in actual cancer diagnoses, indicating its utility in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Fluorodeoxyglucose positron emission/computed tomography for occult cancer among patients with unprovoked venous thromboembolism: What do we know? Delluc, A., Robin, P.[2022]

Citations

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In patients with unprovoked VTE, does the addition of FDG ... Conclusion: Addition of a FDG PET/CT for occult cancer diagnosis was associated with better health outcomes (fewer cases of delayed cancer diagnosis and greater ...

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Cancer Screening for Blood Clots (MVTEP2/SOME2 Trial) The method identified malignancy in 70% of patients with positive results and only 0.7% in those with negative results, indicating its potential effectiveness ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04304651

Screening for Occult Malignancy in Patients with ... FDG-PET/CT which allows a one-stop whole-body imaging, is routinely used for the diagnosis, staging and restaging of various cancers. The MVTEP2 Trial seeks to ...

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F18-fluorodeoxyglucose positron emission tomography in the ... Complete FDG suppression in FL before first transplantation conferred significantly better outcomes and was only opposed by gene expression profiling-defined ...

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A pilot study utilizing whole body 18 F-FDG-PET/CT as a ... In a pilot study, we prospectively investigated the use of FDG-PET/CT to screen for occult malignancy in 40 patients with unprovoked VTE.

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A pilot study utilizing whole body 18 F-FDG-PET/CT as a ... Completion of FDG-PET/CT imaging was feasible and identified abnormal findings requiring additional evaluations in 62.5% of patients. Occult malignancy was ...

8. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39521&ver=7

LCD - Positron Emission Tomography (PET) Scan for ... 18F-PET/CT scans had an overall sensitivity of 88.7% and a specificity of 80.9% whereas CT scans were 75.2% and 90.2%, respectively. Georga et al. (2020) ...

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18F-FDG PET/CT Imaging In Oncology - PMC - PubMed Central F-FDG PET/CT has better sensitivity, specificity and accuracy (43%-78%, 93%-99% and 62%-86%, respectively) than CT and EUS for the detection of distant ...