PET/CT Imaging for Deep Vein Thrombosis

Overseen By Ahmed Tawakol, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: May-Thurner syndrome, Renal dysfunction, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to predict and prevent complications from deep vein thrombosis (DVT), a blood clot in a vein that can cause serious issues like leg pain and skin ulcers. The study employs FDG-PET/CT imaging (a type of PET/CT scan) to examine inflammation in the blood vessels. The aim is to determine if this imaging can predict who will develop post-thrombotic syndrome (PTS), a painful condition affecting many with DVT. Suitable participants have recently been diagnosed with their first case of DVT in a major vein and have not received any special clot-busting treatments. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future DVT care.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must be able to receive anticoagulation therapy to participate.

What prior data suggests that this imaging technique is safe for patients with deep vein thrombosis?

Research has shown that PET/CT scans are generally easy for patients to handle. Studies have safely used these scans to diagnose various conditions, such as deep vein thrombosis (DVT) and related issues. For instance, one study found that using 18F-GP1 PET/CT was safe for patients with serious blood clots, including acute DVT and pulmonary embolism.

Although PET/CT scans involve exposure to low levels of radiation, they are considered safe for most people. Studies have not reported any major side effects directly linked to the scans. Therefore, individuals considering participation in trials using PET/CT imaging can feel confident in its status as a well-established and commonly used diagnostic tool with a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using PET/CT imaging for deep vein thrombosis (DVT) because it offers a new way to observe the condition non-invasively. Unlike traditional methods like ultrasound, which only shows the clot, PET/CT imaging can provide detailed insights into the clot's activity by using FDG, a type of radioactive sugar that highlights metabolic processes. This could potentially help doctors better predict complications like post-thrombotic syndrome (PTS) and tailor treatments more effectively. By understanding these processes more clearly, this imaging method could change how DVT is monitored and managed.

What evidence suggests that this imaging technique is effective for predicting post-thrombotic syndrome?

Research has shown that FDG-PET/CT imaging can detect inflammation in deep vein thrombosis (DVT). This imaging method identifies activity in blood clots, which decreases over time. Detecting inflammation is crucial because it might help predict who will develop post-thrombotic syndrome (PTS), a common issue after DVT. In earlier studies, FDG-PET/CT successfully identified vein inflammation in animals, suggesting it could work similarly in people. Early results indicate that this imaging could be useful in managing DVT and preventing PTS. Participants in this trial will undergo FDG-PET/CT imaging to monitor for the development of PTS. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals over 30 years old who have experienced their first symptomatic, proximal deep vein thrombosis (DVT), with or without concurrent distal DVT or pulmonary embolism. It excludes those with May-Thurner syndrome, life expectancy under 6 months, inability to receive anticoagulation therapy, prior thrombolytic treatment for DVT, symptoms of DVT more than a week before presenting, or renal dysfunction.

Inclusion Criteria

I am over 30 years old.

I have a blood clot in a major vein for the first time, which may also be in my lung.

Exclusion Criteria

I have been diagnosed with May-Thurner syndrome.

You are expected to live for less than 6 months.

My kidney function is reduced with creatinine above 1.5 mg/ml or clearance below 60 ml/min.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Imaging Visit 1

Participants receive a PET/CT scan and contrast-enhanced CT of the lower extremity, and blood labs are drawn

0-7 days after DVT diagnosis

1 visit (in-person)

Imaging Visit 2

Participants receive a PET/CT scan and blood labs are drawn

21-28 days after DVT diagnosis

1 visit (in-person)

Clinical Evaluation 1

Participants are evaluated for symptoms of DVT and PTS, blood labs are drawn, and an ultrasound is performed

6 months after DVT diagnosis

1 visit (in-person)

Clinical Evaluation 2

Participants are evaluated for symptoms of DVT and PTS, blood labs are drawn, and an ultrasound is performed

24 months after DVT diagnosis or time of PTS diagnosis

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• PET/CT

Trial Overview The study aims to use FDG-PET/CT imaging to predict the risk and severity of post-thrombotic syndrome (PTS) in patients with DVT. Eighty participants will undergo PET/CT scans acutely (0-7 days after diagnosis) and sub-acutely (21-28 days later). They'll be monitored for up to two years for PTS signs using clinical scores, ultrasound assessments, and inflammation markers.

How Is the Trial Designed?

Group I: Single Arm: Observation after Imaging Experimental Treatment 1 Intervention

This is a single-arm study, where subjects will be monitored for development of PTS after baseline non-invasive imaging with FDG PET/CT. The experimental interventIon is the PET/CT imaging.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Selective internal radiotherapy (SIRT) with yttrium-90 can lead to significant tumor response in patients with hepatic malignancies, allowing for subsequent liver resection in selected cases, as demonstrated by a mean lesion volume reduction of 475 cm³ in 12 patients.

While SIRT is generally safe with no complications noted post-treatment, the study found a 67% morbidity rate and 11% mortality rate within 90 days after surgery, highlighting the need for careful patient selection and further research to optimize outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver Resection After Selective Internal Radiation Therapy with Yttrium-90: Safety and Outcomes. Mafeld, S., Littler, P., Hayhurst, H., et al.[2020]

In a study of 825 patients with liver malignancies, most extrahepatic shunts causing complications during Selective Internal Radiation Therapy (SIRT) with Y-90 were identified using hepatic digital subtraction angiography (DSA).

However, SPECT/CT imaging revealed additional shunts in 6.5% of patients, leading to further interventions and preventing SIRT in some cases, highlighting the importance of combining imaging techniques for better patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioembolization with Y-90 Glass Microspheres: Do We Really Need SPECT-CT to Identify Extrahepatic Shunts? Theysohn, JM., Ruhlmann, M., Müller, S., et al.[2018]

The study highlights the feasibility of using PET/MR imaging for assessing biodistribution and dosimetry in liver selective internal radiotherapy (SIRT), which is important for effective radionuclide therapies.

PET/MR offers advantages over traditional PET/CT, including better lesion detection and reduced radiation exposure, making it a promising tool for repeated imaging in SIRT dosimetry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

90Yttrium PET/MR-based dosimetry after liver radioembolization (SIRT). Wissmeyer, M., Delattre, BM., Zaidi, H., et al.[2018]

In a study of 212 patients treated with outpatient SIRT (90Y-microspheres) for liver cancers, only 3.3% experienced serious adverse events that required hospitalization, indicating a high safety profile for this treatment.

The average radiation exposure from the treatment was low, with a mean dose rate of 1.88 µSv/h, which is below the national safety threshold for outpatient procedures, further supporting the safety of SIRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient Yttrium-90 microsphere radioembolization: assessment of radiation safety and quantification of post-treatment adverse events causing hospitalization. Aberle, S., Kenkel, D., Becker, AS., et al.[2020]

Selective internal yttrium-90 radioembolization therapy ((90)Y-SIRT) is an effective and safe minimally invasive treatment for liver malignant tumors, supported by clinical applications over the past two decades and recognized by major cancer treatment guidelines.

A consensus was formed by experts from various medical fields to standardize the management and treatment procedures for (90)Y-SIRT, addressing critical aspects such as indications, contraindications, postoperative follow-up, and radiation safety, to enhance treatment safety and success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chinese expert consensus on selective internal radiation therapy with yttrium-90 for primary and metastatic hepatocellular carcinoma]. [2021]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.114.008902

18 F-Fluorodeoxyglucose Positron Emission Tomography ... Noninvasive FDG-PET/CT identifies neutrophil-dependent thrombus inflammation in murine DVT, and demonstrates a time-dependent signal decrease in both murine ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24999680/

Efficacy of FDG PET/CT imaging for venous ... In this short communication, we present results from a proof-of-concept pilot study aimed at providing some preliminary data on the efficacy of FDG PET/CT in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1071358124004768

Thrombosis imaging with positron emission tomography In this review, we discuss PET as a novel molecular imaging strategy for the identification of thrombosis and the insights it can provide into the role ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3564643/

18F-FDG PET in the Evaluation of Acuity of Deep Vein ... 18 F-FDG PET/CT is accurate for detecting acute symptomatic, proximal DVT. Metabolic activity in thrombosed veins decreases with time.

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCIMAGING.120.011898

Cardiovascular Imaging Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography Imaging Predicts Vein Wall Scarring and Statin Benefit in Murine Venous ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4616277/

Positron Emission Tomography Combined With Computed ... From our study, PET-CT is confirmed to have high negative predictive value for the diagnosis of malignancy in patients with unprovoked VTE. However, PET-CT did ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1538783622035681

Current and future perspectives in imaging of venous ... This review provides an overview of the technique, diagnostic accuracy and potential pitfalls of these established and emerging imaging modalities

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3277867/

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.

9. healthcare-in-europe.com healthcare-in-europe.com/en/news/pet-ct-tracer-offers-better-diagnosis-of-acute-venous-thromboembolism.html

PET/CT tracer offers better diagnosis of acute venous ... The safety and diagnostic performance of 18F-GP1 PET/CT were assessed in 20 patients with acute deep-vein thrombosis or pulmonary embolism (10 ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT03937583?term=FLUDEOXYGLUCOSE&rank=7

Screening for Cancer in Patients With Unprovoked VTE The performance of the 18 FDG PET-CT will require fasting of at least 6 hours, and the glycemia will have to be lower than 126 mg / dL before the injection of 3 ...