Trial Outcomes & Findings for Novel PET/CT and Treatment Strategies to Reduce PTS Following DVT (NCT NCT03195777)
NCT ID: NCT03195777
Last Updated: 2026-08-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
6 - 24 month follow-up period
Results posted on
2026-08-18
Participant Flow
We conducted a prospective cohort study at Massachusetts General Hospital (Boston, MA, United States) between 12/20/2017 and 6/27/25
Participant milestones
| Measure |
Single Arm: Observation After Imaging
This is a single-arm study, where subjects were monitored for development of PTS after baseline non-invasive imaging with FDG PET/CT. The experimental interventIon is the PET/CT imaging.
PET/CT: PET/CT imaging was performed (with fluorodeoxyglucose, \[FDG\] as a tracer). Thereafter, subjects will be monitored for development of PTS. We then assessed the ability of PET/CT to predict the subsequent development of PTS.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Novel PET/CT and Treatment Strategies to Reduce PTS Following DVT
Baseline characteristics by cohort
| Measure |
Single Arm: Observation After Imaging
n=50 Participants
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.
PET/CT: 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=298 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=298 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=298 Participants
|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 14.3 • n=298 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=298 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=298 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=298 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=298 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=298 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=298 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=298 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=298 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=298 Participants
|
|
Deep Vein Thrombus target to background ratio
|
1.58 TBR (Target to Background Ratio)
n=298 Participants
|
PRIMARY outcome
Timeframe: 6 - 24 month follow-up periodPopulation: Of 50 subjects initially enrolled, 28 participants completed imaging and follow-up.
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.
Outcome measures
| Measure |
Single Arm: Observation After Imaging
n=28 Participants
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.
PET/CT: 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.
|
|---|---|
|
Hazard Ratio: for Baseline FDG Activity Within the Thrombus vs. the Subsequent Development of Post-thrombotic Syndrome
|
4.09 Hazard Ratio
Interval -0.11 to 26.0
|
Adverse Events
Single Arm: Observation After Imaging
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm: Observation After Imaging
n=50 participants at risk
This is a single-arm study, where subjects were monitored for development of PTS after baseline non-invasive imaging with FDG PET/CT. The experimental interventIon is the PET/CT imaging.
PET/CT: PET/CT imaging was performed (with fluorodeoxyglucose, \[FDG\] as a tracer). Thereafter, subjects will be monitored for development of PTS. We then assessed the ability of PET/CT to predict the subsequent development of PTS.
|
|---|---|
|
Nervous system disorders
Asceptic Meningitis
|
2.0%
1/50 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Urinary Sepsis
|
2.0%
1/50 • Number of events 1 • 24 months
|
|
Infections and infestations
COVID Penumonia
|
2.0%
1/50 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Acute appendicitis
|
2.0%
1/50 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
Single Arm: Observation After Imaging
n=50 participants at risk
This is a single-arm study, where subjects were monitored for development of PTS after baseline non-invasive imaging with FDG PET/CT. The experimental interventIon is the PET/CT imaging.
PET/CT: PET/CT imaging was performed (with fluorodeoxyglucose, \[FDG\] as a tracer). Thereafter, subjects will be monitored for development of PTS. We then assessed the ability of PET/CT to predict the subsequent development of PTS.
|
|---|---|
|
Gastrointestinal disorders
Ulerative Colitis
|
2.0%
1/50 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
interstitial lung disease
|
2.0%
1/50 • Number of events 1 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place