Deep Venous ThrombosisNCT03195777
Novel PET/CT and Treatment Strategies to Reduce PTS Following DVT
A study testing PET/CT in people with Deep Venous Thrombosis and Post-thrombotic Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Deep Venous Thrombosis, Post-thrombotic Syndrome
- What is being tested?
- PET/CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2017to 27 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 30
- Patient presents with a first symptomatic, proximal DVT (with or without concurrent distal DVT or pulmonary embolism).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read more
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.
Read the detailed description
This study is a one-center observational study examining DVT with PET/CT. 80 individuals with recent deep venous thrombosis (DVT) will be recruited from MGH. Imaging and clinical evaluation will be performed to look for predictors of a major complication of DVT: the post-thrombotic syndrome (PTS)
There are 5 visits to attend. The imaging visits will last 2-3 hours. The clinical evaluation visits will last 1-2 hours.
- Screening - This visit will take place after initial DVT (deep venous thrombosis) diagnosis. It will involve clinical assessments and blood labs, to determine subject eligibility. If an ultrasound was not performed at the time of DVT diagnosis, an ultrasound should be performed.
- Visit 1 (0-7 days after DVT diagnosis) - Imaging Visit 1 - At this visit, patients will receive a positron-emission tomography/ computed tomography (PET/CT) scan, and contrast-enhanced CT of the lower extremity (CTA) and will have blood labs drawn.
- Visit 2 (21-28 days after DVT diagnosis) - Imaging Visit 2 - At this visit, patients will receive a PET/CT scan and will have blood labs drawn.
- Visit 3 (6 months after DVT diagnosis) - Clinical Evaluation - At this visit, patients will meet to evaluate symptoms of DVT and PTS. Blood labs will be drawn. An ultrasound will be performed as well.
- Visit 4 (24 months after DVT diagnosis OR time of PTS diagnosis) - Clinical Evaluation - At this visit, patients will meet to evaluate symptoms of DVT and PTS. Blood labs will be drawn. An ultrasound will be performed as well.
- Conditions
- Deep Venous Thrombosis, Post-thrombotic Syndrome
- Being tested
- PET/CT
- Medical subject headings
- Venous Thrombosis, Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazard Ratio: for Baseline FDG Activity Within the Thrombus vs. the Subsequent Development of Post-thrombotic Syndrome
Cox regression assessing the relationship between DVT-associated inflammation (at baseline) and the development of PTS. The predictor is baseline DVT inflammation (as target to background ratio of the FDG signal within the thrombus). The outcome is the development of post-thrombotic syndrome (defined as Villata Score >/= 5 ) at any time during the 6- 24 months follow-up period.
Measured: 6 - 24 month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start20 Dec 2017
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ahmed Tawakol, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195777
- Sponsor's protocol ID
- 2017P000808
- Other IDs
- R01HL137913
- Status last verified
- Jul 2026
- First submitted
- 20 Jun 2017
- Last updated
- 18 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25070665Jamie Bellinge, Rachel Rosovsky, Shady Abohashem, Hui Chong Lau, Wesam Aldosoky, Alula Assefa, Michael Thomas Osborne, Farouc A. Jaffer, and Ahmed A. Tawakol. DEEP VEIN THROMBOSIS INFLAMMATION IS ASSOCIATED WITH A HEIGHTENED RISK OF POST-THROMBOTIC SYNDROME - A PROSPECTIVE COHORT STUDY. Journal of the American College of Cardiology 2026. 87(13) Pages: A937 - A938
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel PET/CT and Treatment Strategies to Reduce PTS Following DVT
- ClinicalTrials.gov ID
- NCT03195777
- Acronym / sponsor ID
- 2017P000808
- Conditions
- Deep Venous Thrombosis, Post-thrombotic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Posted 18 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a one-center observational study examining DVT with PET/CT. 80 individuals with recent deep venous thrombosis (DVT) will be recruited from MGH. Imaging and clinical evaluation will be performed to look for predictors of a major complication of DVT: the post-thrombotic syndrome (PTS)
There are 5 visits to attend. The imaging visits will last 2-3 hours. The clinical evaluation visits will last 1-2 hours.
- Screening - This visit will take place after initial DVT (deep venous thrombosis) diagnosis. It will involve clinical assessments and blood labs, to determine subject eligibility. If an ultrasound was not performed at the time of DVT diagnosis, an ultrasound should be performed.
- Visit 1 (0-7 days after DVT diagnosis) - Imaging Visit 1 - At this visit, patients will receive a positron-emission tomography/ computed tomography (PET/CT) scan, and contrast-enhanced CT of the lower extremity (CTA) and will have blood labs drawn.
- Visit 2 (21-28 days after DVT diagnosis) - Imaging Visit 2 - At this visit, patients will receive a PET/CT scan and will have blood labs drawn.
- Visit 3 (6 months after DVT diagnosis) - Clinical Evaluation - At this visit, patients will meet to evaluate symptoms of DVT and PTS. Blood labs will be drawn. An ultrasound will be performed as well.
- Visit 4 (24 months after DVT diagnosis OR time of PTS diagnosis) - Clinical Evaluation - At this visit, patients will meet to evaluate symptoms of DVT and PTS. Blood labs will be drawn. An ultrasound will be performed as well.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Observation after Imaging | Experimental | Device: PET/CTThis 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 may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age above 30
- Patient presents with a first symptomatic, proximal DVT (with or without concurrent distal DVT or pulmonary embolism).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CTPET/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. | Device | Single Arm: Observation after Imaging |
Primary outcome
Hazard Ratio: for Baseline FDG Activity Within the Thrombus vs. the Subsequent Development of Post-thrombotic Syndrome
Time frame: 6 - 24 month follow-up period
Cox regression assessing the relationship between DVT-associated inflammation (at baseline) and the development of PTS. The predictor is baseline DVT inflammation (as target to background ratio of the FDG signal within the thrombus). The outcome is the development of post-thrombotic syndrome (defined as Villata Score >/= 5 ) at any time during the 6- 24 months follow-up period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25070665Hara 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.
- Results publicationJamie Bellinge, Rachel Rosovsky, Shady Abohashem, Hui Chong Lau, Wesam Aldosoky, Alula Assefa, Michael Thomas Osborne, Farouc A. Jaffer, and Ahmed A. Tawakol. DEEP VEIN THROMBOSIS INFLAMMATION IS ASSOCIATED WITH A HEIGHTENED RISK OF POST-THROMBOTIC SYNDROME - A PROSPECTIVE COHORT STUDY. Journal of the American College of Cardiology 2026. 87(13) Pages: A937 - A938
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT in people with Deep Venous Thrombosis and Post-thrombotic Syndrome, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hazard Ratio: for Baseline FDG Activity Within the Thrombus vs. the Subsequent Development of Post-thrombotic Syndrome (time frame: 6 - 24 month follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03195777, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.