Novel PET/CT and Treatment Strategies to Reduce PTS Following DVT

NCT03195777 | Completed FDA Device

• 1 other identifier: 2017P000808
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to develop strategies that will improve outcomes for patients with deep vein thrombosis (DVT), using in vivo FDG-PET inflammation imaging to better predict the development of the post-thrombotic syndrome (PTS). New approaches are needed to improve the outcomes of patients with DVT, a disease that affects up to 600,000 patients per year in the US alone. DVT acutely places patients at risk of death from pulmonary embolism and causes 50,000 deaths annually in the US. Moreover, up to 30-50% of patients will develop PTS, an illness characterized by inflammation-driven fibrotic vein wall injury, and persistent thrombus obstruction. PTS occurs despite anticoagulant therapy, and produces chronic disability from leg pain, heaviness, edema, skin pigmentation, and ulcers; some patients may even require amputation. PTS impairs quality of life to the same extent as chronic obstructive pulmonary disease or diabetes. Therefore new diagnostic insights into PTS are urgently needed. There are several major challenges to improve outcomes in PTS: A) Limited in vivo knowledge regarding inflammation and the development of PTS; B) L Lack of predictive approaches to identify patients at high risk for PTS that will preferentially benefit from novel therapies. Recently, our laboratories have harnessed FDG-PET molecular imaging to illuminate DVT inflammation in vivo, and to provide a new strategy to diagnose recurrent DVT, a vexing clinical problem (Hara et al. Circulation 2014). We now propose to further develop FDG-PET to improve outcomes in DVT and PTS. The objective of this application is to develop FDG-PET as an inflammation imaging approach to assess DVT inflammation and predict risk of developing PTS in human subjects; Hypothesis 1A: Inflammatory activity in DVT (quantified acutely, using FDG-PET imaging within 0-7 days after DVT) will predict PTS incidence (primary) and severity (secondary) within a 24 month follow-up period. Hypothesis 1B: Inflammatory activity in DVTs (quantified sub-acutely, using FDG-PET imaging within 21-28 days after DVT), will predict PTS incidence and severity. Eighty patients with DVT will be imaged using FDG-PET/CT acutely (0-7 days of DVT diagnosis), and sub-acutely (21-28 days after diagnosis). Subjects will be evaluated repeatedly for up to 2 years to detect clinical evidence of PTS (Villalta score), ultrasound findings for structural venous injury, and soluble biomarkers of systemic inflammation. Subsequently, we will evaluate the relationship between FDG DVT activity and the development of PTS.

Conditions

Deep Venous Thrombosis; Post-thrombotic Syndrome

Outcome Measures

Primary Outcomes (1)

• PTS incidence

  Incidence of PTS (by Villalta score of ≥5) at any time during 24 months of observation after diagnosis of first proximal DVT

  24 month follow-up period

Secondary Outcomes (1)

• PTS severity

  24 month follow-up period

Study Arms (1)

Single Arm: Observation after Imaging

EXPERIMENTAL

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.

Device: PET/CT

Interventions

PET/CT DEVICE

PET/CT imaging will be performed (with fluorodeoxyglucose, \[FDG\] as a tracer). Thereafter, subjects will be monitored for development of PTS. We will then assess the ability of PET/CT top predict the subsequent development of PTS.

Single Arm: Observation after Imaging

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 30
• Patient presents with a first symptomatic, proximal DVT (with or without concurrent distal DVT or pulmonary embolism).

You may not qualify if:

• Patient has May-Thurner syndrome
• Patient has an expected life span of \< 6 months
• Patient can't receive anticoagulation therapy
• Patient received thrombolytic therapy for the initial treatment of acute DVT
• Patient has DVT signs of symptoms that occur more than 1 week prior to presentation, as assessed by clinical history
• Renal dysfunction (Serum creatinine \> 1.5 mg/ml or estimated creatinine clearance \< 60 ml/min)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Hara T, Truelove J, Tawakol A, Wojtkiewicz GR, Hucker WJ, MacNabb MH, Brownell AL, Jokivarsi K, Kessinger CW, Jaff MR, Henke PK, Weissleder R, Jaffer FA. 18F-fluorodeoxyglucose positron emission tomography/computed tomography enables the detection of recurrent same-site deep vein thrombosis by illuminating recently formed, neutrophil-rich thrombus. Circulation. 2014 Sep 23;130(13):1044-52. doi: 10.1161/CIRCULATIONAHA.114.008902. Epub 2014 Jul 28.

  PMID: 25070665 RESULT

MeSH Terms

Conditions

Venous Thrombosis; Postthrombotic Syndrome

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Investigators who are analyzing images will be blinded to all clinical data, including clinical follow-up data to determine PTS
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interim Director, Nuclear Cardiology

Model Details: This study is a one-center observational study examining DVT with FDG- PET/CT. 80 individuals with DVT will be imaged with PET/CT and followed for development of PTS

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: December 20, 2017
• Primary Completion: June 8, 2025
• Study Completion: June 8, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)