Cancer Screening for Blood Clots

(MVTEP2/SOME2 Trial)

Recruiting in Palo Alto (17 mi)

+19 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University Hospital, Brest

Must not be taking: Anticoagulants

Disqualifiers: Active malignancy, Recent paralysis, others

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.

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.

What data supports the effectiveness of this treatment for cancer screening for blood clots?

Research shows that FDG PET/CT, a type of imaging test, is effective in detecting hidden cancers in patients with unexplained blood clots. It has high sensitivity, meaning it can accurately identify cancer, and often leads to a correct cancer diagnosis when further tests are done after a positive result. ^{1 2 3 4 5}

Is FDG-PET/CT screening safe for humans?

FDG-PET/CT screening involves exposure to radiation, which is a consideration in its use, but it has been widely used in cancer screening programs, suggesting it is generally considered safe for humans when the benefits outweigh the risks. ^{6 7 8 9 10}

How is the treatment 'Limited cancer screening + FDG PET/CT' unique for detecting blood clots related to cancer?

This treatment is unique because it uses FDG PET/CT, a type of imaging that helps identify cancer-related blood clots by distinguishing them from non-cancerous clots, which can guide appropriate treatment decisions. ^{1 2 6 7 10}

Research Team

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

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.

Trial Timeline

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

Treatment Details

Interventions

• Limited cancer screening (Diagnostic Test)
• Limited cancer screening + FDG PET/CT (Diagnostic Test)

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.

Participant Groups

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+

Dr. Robert J. Corona

University Hospital, Brest

Chief Executive Officer since 2020

DO, MBA from Cornell University

Dr. Amy Tucker

University Hospital, Brest

Chief Medical Officer since 2020

MD, MHCM

Ministry of Health, France

Collaborator

Trials

383

Recruited

722,000+

Anne-Sophie Lapointe

Ministry of Health, France

Chief Medical Officer since 2023

MD, Public Health at the French School of Public Health (EHESP)

Louisa Stüwe

Ministry of Health, France

Chief Executive Officer since 2022

Public Administration and International Politics at Sciences Po Paris and Georgetown University

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa

Ottawa Hospital Research Institute

Collaborator

Trials

585

Recruited

3,283,000+

Dr. Kathleen Gartke

Ottawa Hospital Research Institute

Chief Medical Officer

MD, University of Ottawa

Dr. Rebecca Auer

Ottawa Hospital Research Institute

Chief Executive Officer

MD, Memorial Sloan-Kettering Cancer Centre

Findings from Research

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 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]

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]

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]

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 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 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]

References

1. India pubmed.ncbi.nlm.nih.gov

Rare case of an ovarian vein tumor thrombosis identified on fluorodeoxyglucose positron emission tomography/computed tomography. [2020]

2. United States 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. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Utility of FDG PET/CT for assessment of lung nodules identified during low dose computed tomography screening. [2021]

5. Greece pubmed.ncbi.nlm.nih.gov

Application of PET and PEt/CT imaging for cancer screening. [2016]

6. Greece pubmed.ncbi.nlm.nih.gov

Detection of thyroid cancer by an FDG-PET cancer screening program: a Japanese nation-wide survey. [2016]

7. United States 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. [2021]

8. Japan pubmed.ncbi.nlm.nih.gov

Radiation exposure and risk-benefit analysis in cancer screening using FDG-PET: results of a Japanese nationwide survey. [2016]

9. Japan 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. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Detection of breast cancer in an FDG-PET cancer screening program: results of a nationwide Japanese survey. [2016]