Your session is about to expire
← Back to Search
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 month follow-up period
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am over 30 years old.
Select...
I have a blood clot in a major vein for the first time, which may also be in my lung.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PTS incidence
Secondary outcome measures
PTS severity
Side effects data
From 2020 Phase 1 & 2 trial • 88 Patients • NCT023389999%
White blood cell count decreased
9%
Upper respiratory tract infection
6%
Fatigue
6%
Alanine aminotransferase increased
5%
Nausea
5%
Pain in extremity
5%
Dizziness
4%
Viral upper respiratory tract infection
4%
Anaemia
4%
Cardiac murmur
4%
Weight increased
4%
Dysuria
4%
Abdominal distension
3%
Gastritis
3%
Rhinitis allergic
3%
Paraesthesia
3%
Headache
3%
Somnolence
3%
Dyspepsia
3%
Aspartate aminotransferase increased
3%
Micturition disorder
3%
Dyspnoea
3%
Wheezing
3%
Platelet count decreased
1%
Fall
1%
Leukopenia
1%
Gastrooesophageal reflux disease
1%
Abdominal pain
1%
Lymphadenopathy
1%
Episcleritis
1%
Urinary tract infection
1%
Computerised tomogram coronary artery abnormal
1%
Arthropod bite
1%
Laryngeal inflammation
1%
Oedema peripheral
1%
Vaginal infection
1%
Pharyngitis
1%
Gastritis viral
1%
Frequent bowel movements
1%
Numbness
1%
Blood bicarbonate decreased
1%
Myalgia
1%
Fluid retention
1%
Decreased appetite
1%
Weight decreased
1%
Memory impairment
1%
Computerised tomogram abnormal
1%
Anorexia nervosa
1%
Hypertriglyceridaemia
1%
Vomiting
1%
Biopsy lymph gland
1%
Muscle spasms
1%
Disturbance in attention
1%
Blood creatinine increased
1%
Insomnia
1%
Panic attack
1%
Hot flush
1%
Lacrimation increased
1%
Constipation
1%
Diarrhoea
1%
Dysphagia
1%
Influenza like illness
1%
Localised oedema
1%
Herpes zoster
1%
Sinusitis
1%
Increased appetite
1%
Chills
1%
Galactorrhoea
1%
Cough
1%
Pain of Skin
1%
Pruritus
1%
Thyroid mass
1%
Helicobacter test positive
1%
Lymphocyte count decreased
1%
Neutrophil count decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pioglitazone
Placebo
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
~1240
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,305 Total Patients Enrolled
5 Trials studying Deep Vein Thrombosis
1,686 Patients Enrolled for Deep Vein Thrombosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with May-Thurner syndrome.You are expected to live for less than 6 months.My kidney function is reduced with creatinine above 1.5 mg/ml or clearance below 60 ml/min.I am over 30 years old.I cannot take blood thinners.I have a blood clot in a major vein for the first time, which may also be in my lung.I received clot-dissolving medication for my initial deep vein thrombosis treatment.I have had signs or symptoms of a blood clot for more than a week.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm: Observation after Imaging
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment to this experiment still available for participants?
"Clinicaltrials.gov reports that this research is still enrolling patients, with the initial posting made on December 20th 2017 and newer data being added as recently as April 17th 2022."
Answered by AI
What is the capacity of participants in this clinical research?
"Indeed, the information presented on clinicaltrials.gov reveals that this research endeavour is looking for participants. Started in December 20th 2017 and recently updated April 17th 2022, this study aims to include 80 individuals from a single location."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger