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PET/CT Imaging for Deep Vein Thrombosis

N/A

Waitlist Available

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age above 30

Patient presents with a first symptomatic, proximal DVT (with or without concurrent distal DVT or pulmonary embolism).

Must not have

Patient has May-Thurner syndrome

Renal dysfunction (Serum creatinine > 1.5 mg/ml or estimated creatinine clearance < 60 ml/min)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 month follow-up period

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to improve outcomes for patients with deep vein thrombosis (DVT) by using in vivo FDG-PET inflammation imaging to better predict the development of the post-thrombotic syndrome (PTS).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial description does not specify side effects related directly to the FDG-PET/CT imaging used in this study, typical risks may include exposure to radiation from the CT scan and potential allergic reactions to contrast agents if used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 30 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with May-Thurner syndrome.

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

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I cannot take blood thinners.

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I received clot-dissolving medication for my initial deep vein thrombosis treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 month follow-up period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 month follow-up period

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 month follow-up period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PTS incidence

Secondary study objectives

PTS severity

Side effects data

From 2020 Phase 1 & 2 trial • 88 Patients • NCT02338999

White blood cell count decreased

Upper respiratory tract infection

Fatigue

Alanine aminotransferase increased

Nausea

Pain in extremity

Dizziness

Viral upper respiratory tract infection

Anaemia

Cardiac murmur

Weight increased

Dysuria

Abdominal distension

Rhinitis allergic

Gastritis

Paraesthesia

Headache

Somnolence

Dyspepsia

Aspartate aminotransferase increased

Micturition disorder

Dyspnoea

Wheezing

Platelet count decreased

Pharyngitis

Urinary tract infection

Numbness

Computerised tomogram coronary artery abnormal

Arthropod bite

Laryngeal inflammation

Frequent bowel movements

Lymphadenopathy

Episcleritis

Fall

Leukopenia

Gastrooesophageal reflux disease

Abdominal pain

Gastritis viral

Vaginal infection

Oedema peripheral

Blood bicarbonate decreased

Myalgia

Fluid retention

Decreased appetite

Weight decreased

Memory impairment

Computerised tomogram abnormal

Anorexia nervosa

Hypertriglyceridaemia

Vomiting

Biopsy lymph gland

Muscle spasms

Disturbance in attention

Blood creatinine increased

Insomnia

Panic attack

Hot flush

Lacrimation increased

Constipation

Diarrhoea

Dysphagia

Influenza like illness

Localised oedema

Herpes zoster

Sinusitis

Increased appetite

Chills

Galactorrhoea

Cough

Pain of Skin

Pruritus

Thyroid mass

Helicobacter test positive

Lymphocyte count decreased

Neutrophil count decreased

100%

80%

60%

40%

20%

Study treatment Arm

Pioglitazone

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single Arm: Observation after ImagingExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET/CT

2022

Completed Phase 3

~1300

0 / 6Eligibility criteria met