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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL141900 | U.S. NIH Grant/Contract | View source |
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The study did not reach its enrollment target due to a relatively narrow time window for imaging after the contrast CT imaging confirmed PE and limitations in the availability of the tracer and the PET scanner.
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute pulmonary embolism | Experimental | Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 64Cu-FBP8 | Drug | Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Location of the Thrombus Within the Lungs | 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. | 72 hours |
| Location of Clot Burden Measurements Within the Thigh | To determine the location of the thrombus ROI within the thigh using PET-CT imaging in comparison to the clot on venous duplex ultrasound. | 72 hours |
| Assessment of 64Cu-FBP8 Fibrin Activity in the Pelvic Veins and Upper Extremity | The presence or absence of blood clots as assessed by high 64Cu-FBP8 fibrin activity in the pelvic veins and upper extremities will be reported. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Normalized 64Cu-FBP8 Fibrin Activity and Plasma D-dimer | 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. Outcome measure is the value of the Pearson correlation coefficient . | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tilo Winkler, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Of 6 enrolled participants, 64Cu-FBP8 PET imaging studies were conducted in 5 participants; one participant withdrew before PET imaging.
Participants were recruited between May 2018 and August 2022 based on a PE diagnosis confirmed by CT pulmonary angiogram (CTPA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Acute Pulmonary Embolism | Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Including all recruited participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Acute Pulmonary Embolism | Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Location of the Thrombus Within the Lungs | 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. | Posted | Count of Participants | Participants | 72 hours |
|
|
After 64Cu-FBP8 injection, during PET imaging, and 24 hours monitoring. The all-cause mortality is based on the last follow-up after 12 months, including the participant who withdrew from the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acute Pulmonary Embolism | Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tilo Winkler | Mass General Hospital | 617 724-4083 | twinkler@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2022 | Nov 26, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D020246 | Venous Thrombosis |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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Subjects with acute pulmonary embolism meeting the inclusion criteria will be enrolled.
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| PET-CT imaging | Diagnostic Test | All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8. |
|
| Overall Clot Burden Within the Lungs |
Overall clot burden calculated as sum of 64Cu-FBP8 activity within a thrombus ROI(s) within the lungs. This is reported in 4 different ways:
|
| 4 hours |
| Overall Clot Burden Within the Thigh | Overall clot burden calculated as sum of 64Cu-FBP8 activity within a thrombus ROI(s) within the thigh. This is reported as: TBRmean of the thrombus which is the ratio of the mean PET signal in the thrombus within the thigh divided by the mean PET signal in the blood pool | 4 hours |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| D-dimer | Mean | Full Range | ng/ml |
|
|
|
| Primary | Location of Clot Burden Measurements Within the Thigh | To determine the location of the thrombus ROI within the thigh using PET-CT imaging in comparison to the clot on venous duplex ultrasound. | Posted | Count of Participants | Participants | 72 hours |
|
|
|
| Primary | Assessment of 64Cu-FBP8 Fibrin Activity in the Pelvic Veins and Upper Extremity | The presence or absence of blood clots as assessed by high 64Cu-FBP8 fibrin activity in the pelvic veins and upper extremities will be reported. | Posted | Count of Participants | Participants | 4 hours |
|
|
|
| Secondary | Correlation Between Normalized 64Cu-FBP8 Fibrin Activity and Plasma D-dimer | 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. Outcome measure is the value of the Pearson correlation coefficient . | Posted | Number | Pearson correlation coefficient | 4 hours |
|
|
|
| Secondary | Overall Clot Burden Within the Lungs | Overall clot burden calculated as sum of 64Cu-FBP8 activity within a thrombus ROI(s) within the lungs. This is reported in 4 different ways:
| Posted | Mean | Full Range | Unitless ratio | 4 hours |
|
|
|
| Secondary | Overall Clot Burden Within the Thigh | Overall clot burden calculated as sum of 64Cu-FBP8 activity within a thrombus ROI(s) within the thigh. This is reported as: TBRmean of the thrombus which is the ratio of the mean PET signal in the thrombus within the thigh divided by the mean PET signal in the blood pool | Posted | Mean | Standard Deviation | Unitless ratio | 4 hours |
|
|
|
| 2 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
| D013923 | Thromboembolism |
| Title | Measurements |
|---|---|
|
| SUVmax of the PE |
|