Novel PET/CT and Treatment Strategies to Reduce PTS Following DVT
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 1/3/2019 |
| Start Date: | December 20, 2017 |
| End Date: | June 30, 2022 |
| Contact: | Ahmed Tawakol, MD |
| Email: | atawakol@mgh.harvard.edu |
| Phone: | 617-726-0791 |
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.
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.
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.
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
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.
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
Inclusion Criteria:
- Age above 30
- Patient presents with a first symptomatic, proximal DVT (with or without concurrent
distal DVT or pulmonary embolism).
Exclusion Criteria:
- 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)
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-0791
Click here to add this to my saved trials
