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出境医 / 临床实验 / PET Fibrin Imaging of DVT and PE

PET Fibrin Imaging of DVT and PE

Study Description
Brief Summary:
This study aims to investigate a novel positron emission tomography(PET)-probe for imaging of fresh intravascular blood clots in pulmonary embolism (PE) and deep venous thrombosis (DVT).

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Deep Vein Thrombosis Venous Thromboembolism Drug: 64Cu-FBP8 Diagnostic Test: PET-CT imaging Phase 1

Detailed Description:
Venous thromboembolism (VTE) is one of the most common causes of death in the United States, resulting in more than 100,000 deaths annually. Current diagnostic techniques rely on indirect measures of clot for diagnosis and therefore suffer from the problems of both under and overdiagnosis and cannot always be performed on patients with renal failure and lung disease. In this study, we will use the novel fibrin-specific probe 64CU-FBP8 (Copper-64 labeled fibrin binding probe 8) for PET imaging of fresh blood clots in PE and DVT. Our long-term goal is to establish a novel thrombus body scan (TBS) using 64CU-FBP8 for PET imaging to overcome the limitations of indirect venous thromboembolism diagnosis, and, with one single test, provide a total-body assessment of fresh intravascular clot.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects with acute pulmonary embolism meeting the inclusion criteria will be enrolled.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET Fibrin Imaging of DVT and PE
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : May 13, 2023
Estimated Study Completion Date : May 31, 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: Acute pulmonary embolism
Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging.
 Drug: 64Cu-FBP8
Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject.

Diagnostic Test: PET-CT imaging
All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8.
Outcome Measures
Primary Outcome Measures :
  1. Location of the thrombus within the lungs [ Time Frame: 4 hours ]
    To determine the location of the thrombus regions of interest (ROIs) within the lungs using PET-CT imaging in comparison to the ROI of filling defects on CT-angiogram.

  2. Location of clot burden measurements within the thigh [ Time Frame: 4 hours ]
    To determine the location of the thrombus ROI within the thigh using PET-CT imaging in comparison to the clot on venous duplex ultrasound.

  3. Assessment of 64Cu-FBP8 fibrin activity in the pelvic and upper extremity [ Time Frame: 4 hours ]
    The prevalence of high 64Cu-FBP8 fibrin activity in the pelvic ROI and upper extremity ROI's will be reported.


Secondary Outcome Measures :
  1. Correlation between normalized 64Cu-FBP8 fibrin activity and plasma D-dimer [ Time Frame: 4 hours ]
    Correlation of the total fibrin activity in the imaged fields, excluding the liver, gallbladder, kidneys and urinary bladder normalized by injected dose with the plasma D-dimer.

  2. Overall clot burden within the lungs [ Time Frame: 4 hours ]
    Overall clot burden calculated as sum of 64Cu-FBP8 activity within a thrombus ROI(s) within the lungs.

  3. Overall clot burden within the thigh [ Time Frame: 4 hours ]
    Overall clot burden calculated as sum of 64Cu-FBP8 activity within a thrombus ROI(s) within the thigh.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older with a clinically significant pulmonary embolus (PE) confirmed by a filling defect in CT angiography (CTA), and
  • Subjects must receive the radiotracer injection within 72 hours of their diagnosis.

Exclusion Criteria:

  • Subjects < 18 years of age
  • Time of expected radiotracer injection > 72 hours from the time of a positive venous duplex ultrasound or CT- angiogram
  • Women subjects of childbearing potential who are pregnant, seeking to become pregnant, or have a positive serum pregnancy (beta-HCG) test
  • Unable to lie flat for 45 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis, dyspnea),
  • Weight that exceeds the PET camera table limit (300 kg)
  • The subject will not be enrolled in the study if the radiation exposure for research studies during the prior 12 months, combined with the exposure from this study would exceed 50 mSv (millisievert).
  • Due to the radiation exposure from imaging studies, all women of childbearing potential will be required to have a negative serum pregnancy test performed prior to any imaging procedures on the same day (if not already done that day). Patients with a positive serum pregnancy test will be excluded. Breast feeding women will also be excluded.
  • A pre-existing condition or use of a medication including vasopressors and tPA (tissue Plasminogen Activator) that in the opinion of the investigator may place the subject at a substantially increased risk
  • Hemodynamic instability, including requiring escalating doses of vasopressor medication.
  • No groups designated as "special vulnerable populations" will be studied.
  • No exclusions will be made based on race, sex, or ethnic origin.
  • 64Cu-FBP8 (Copper-64 labeled fibrin binding probe 8) is cleared by the kidneys, patients with eGFR (estimated Glomerular Filtration Rate ) < 30 will be excluded.
Contacts and Locations

Contacts
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Contact: Tilo Winkler, PhD 617-724-4083 twinkler@mgh.harvard.edu
Contact: Mamary T Kone, MD, MPH 617-726-1082 mkone@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Tilo Winkler, PhD    617-724-4083    twinkler@mgh.harvard.edu   
Sponsors and Collaborators
Peter David Caravan
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Tilo Winkler, PhD Massachusetts General Hospital
Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 17, 2019
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE May 13, 2019
Estimated Primary Completion Date May 13, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • Location of the thrombus within the lungs [ Time Frame: 4 hours ]
    To determine the location of the thrombus regions of interest (ROIs) within the lungs using PET-CT imaging in comparison to the ROI of filling defects on CT-angiogram.
  • Location of clot burden measurements within the thigh [ Time Frame: 4 hours ]
    To determine the location of the thrombus ROI within the thigh using PET-CT imaging in comparison to the clot on venous duplex ultrasound.
  • Assessment of 64Cu-FBP8 fibrin activity in the pelvic and upper extremity [ Time Frame: 4 hours ]
    The prevalence of high 64Cu-FBP8 fibrin activity in the pelvic ROI and upper extremity ROI's will be reported.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • Correlation between normalized 64Cu-FBP8 fibrin activity and plasma D-dimer [ Time Frame: 4 hours ]
    Correlation of the total fibrin activity in the imaged fields, excluding the liver, gallbladder, kidneys and urinary bladder normalized by injected dose with the plasma D-dimer.
  • Overall clot burden within the lungs [ Time Frame: 4 hours ]
    Overall clot burden calculated as sum of 64Cu-FBP8 activity within a thrombus ROI(s) within the lungs.
  • Overall clot burden within the thigh [ Time Frame: 4 hours ]
    Overall clot burden calculated as sum of 64Cu-FBP8 activity within a thrombus ROI(s) within the thigh.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PET Fibrin Imaging of DVT and PE
Official Title  ICMJE PET Fibrin Imaging of DVT and PE
Brief Summary This study aims to investigate a novel positron emission tomography(PET)-probe for imaging of fresh intravascular blood clots in pulmonary embolism (PE) and deep venous thrombosis (DVT).
Detailed Description Venous thromboembolism (VTE) is one of the most common causes of death in the United States, resulting in more than 100,000 deaths annually. Current diagnostic techniques rely on indirect measures of clot for diagnosis and therefore suffer from the problems of both under and overdiagnosis and cannot always be performed on patients with renal failure and lung disease. In this study, we will use the novel fibrin-specific probe 64CU-FBP8 (Copper-64 labeled fibrin binding probe 8) for PET imaging of fresh blood clots in PE and DVT. Our long-term goal is to establish a novel thrombus body scan (TBS) using 64CU-FBP8 for PET imaging to overcome the limitations of indirect venous thromboembolism diagnosis, and, with one single test, provide a total-body assessment of fresh intravascular clot.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Subjects with acute pulmonary embolism meeting the inclusion criteria will be enrolled.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Pulmonary Embolism
  • Deep Vein Thrombosis
  • Venous Thromboembolism
Intervention  ICMJE
  • Drug: 64Cu-FBP8
    Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject.
  • Diagnostic Test: PET-CT imaging
    All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8.
Study Arms  ICMJE Experimental: Acute pulmonary embolism
Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging.
Interventions:
  • Drug: 64Cu-FBP8
  • Diagnostic Test: PET-CT imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2019) 		80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2024
Estimated Primary Completion Date May 13, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or older with a clinically significant pulmonary embolus (PE) confirmed by a filling defect in CT angiography (CTA), and
  • Subjects must receive the radiotracer injection within 72 hours of their diagnosis.

Exclusion Criteria:

  • Subjects < 18 years of age
  • Time of expected radiotracer injection > 72 hours from the time of a positive venous duplex ultrasound or CT- angiogram
  • Women subjects of childbearing potential who are pregnant, seeking to become pregnant, or have a positive serum pregnancy (beta-HCG) test
  • Unable to lie flat for 45 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis, dyspnea),
  • Weight that exceeds the PET camera table limit (300 kg)
  • The subject will not be enrolled in the study if the radiation exposure for research studies during the prior 12 months, combined with the exposure from this study would exceed 50 mSv (millisievert).
  • Due to the radiation exposure from imaging studies, all women of childbearing potential will be required to have a negative serum pregnancy test performed prior to any imaging procedures on the same day (if not already done that day). Patients with a positive serum pregnancy test will be excluded. Breast feeding women will also be excluded.
  • A pre-existing condition or use of a medication including vasopressors and tPA (tissue Plasminogen Activator) that in the opinion of the investigator may place the subject at a substantially increased risk
  • Hemodynamic instability, including requiring escalating doses of vasopressor medication.
  • No groups designated as "special vulnerable populations" will be studied.
  • No exclusions will be made based on race, sex, or ethnic origin.
  • 64Cu-FBP8 (Copper-64 labeled fibrin binding probe 8) is cleared by the kidneys, patients with eGFR (estimated Glomerular Filtration Rate ) < 30 will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tilo Winkler, PhD 617-724-4083 twinkler@mgh.harvard.edu
Contact: Mamary T Kone, MD, MPH 617-726-1082 mkone@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04022915
Other Study ID Numbers  ICMJE 2018P000523
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter David Caravan, Massachusetts General Hospital
Study Sponsor  ICMJE Peter David Caravan
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Tilo Winkler, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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