Trial Outcomes & Findings for PET Fibrin Imaging of DVT and PE (NCT NCT04022915)

Last Updated: 2026-03-18

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

6 participants

Primary outcome timeframe

72 hours

Results posted on

2026-03-18

Participant Flow

Participants were recruited between May 2018 and August 2022 based on a PE diagnosis confirmed by CT pulmonary angiogram (CTPA).

Of 6 enrolled participants, 64Cu-FBP8 PET imaging studies were conducted in 5 participants; one participant withdrew before PET imaging.

Participant milestones

Participant milestones
Measure	Acute Pulmonary Embolism Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Acute Pulmonary Embolism Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

PET Fibrin Imaging of DVT and PE

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acute Pulmonary Embolism n=6 Participants Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging.
Age, Continuous	61.8 years n=110 Participants
Sex: Female, Male Female	3 Participants n=110 Participants
Sex: Female, Male Male	3 Participants n=110 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=110 Participants
Race (NIH/OMB) Asian	0 Participants n=110 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=110 Participants
Race (NIH/OMB) Black or African American	2 Participants n=110 Participants
Race (NIH/OMB) White	3 Participants n=110 Participants
Race (NIH/OMB) More than one race	0 Participants n=110 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=110 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=110 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=110 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=110 Participants
D-dimer	2814 ng/ml n=110 Participants

PRIMARY outcome

Timeframe: 72 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.

Outcome measures

Outcome measures
Measure	Acute Pulmonary Embolism n=5 Participants Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging. 64Cu-FBP8: Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject. PET-CT imaging: All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8.
Location of the Thrombus Within the Lungs Blood clots in same left-right lung location in PET and CTPA	2 Participants
Location of the Thrombus Within the Lungs Blood clots in same left-right lung location in PET as in CTPA and on the other side	2 Participants
Location of the Thrombus Within the Lungs No blood clots in PET	1 Participants

PRIMARY outcome

Timeframe: 72 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.

Outcome measures

Outcome measures
Measure	Acute Pulmonary Embolism n=5 Participants Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging. 64Cu-FBP8: Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject. PET-CT imaging: All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8.
Location of Clot Burden Measurements Within the Thigh No evidence for clots	5 Participants
Location of Clot Burden Measurements Within the Thigh Evidence for clots	0 Participants

PRIMARY outcome

Timeframe: 4 hours

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.

Outcome measures

Outcome measures
Measure	Acute Pulmonary Embolism n=5 Participants Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging. 64Cu-FBP8: Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject. PET-CT imaging: All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8.
Assessment of 64Cu-FBP8 Fibrin Activity in the Pelvic Veins and Upper Extremity Evidence for clots	0 Participants
Assessment of 64Cu-FBP8 Fibrin Activity in the Pelvic Veins and Upper Extremity No evidence for clots	5 Participants

SECONDARY outcome

Timeframe: 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. Outcome measure is the value of the Pearson correlation coefficient .

Outcome measures

Outcome measures
Measure	Acute Pulmonary Embolism n=5 Participants Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging. 64Cu-FBP8: Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject. PET-CT imaging: All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8.
Correlation Between Normalized 64Cu-FBP8 Fibrin Activity and Plasma D-dimer	0 Pearson correlation coefficient

SECONDARY outcome

Timeframe: 4 hours

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: 1. TBRmean of the PE which is the ratio of the mean PET signal in the pulmonary embolus (clot) divided by the mean PET signal in the blood pool 2. TBRmax of the PE which is the ratio of the maximum PET signal in the pulmonary embolus (clot) divided by the mean PET signal in the blood pool 3. SUVmean of the PE which is the mean standardized uptake value (SUV) in the pulmonary embolus (clot) 4. SUVmax of the PE which is the maximum standardized uptake value (SUV) in the pulmonary embolus (clot)

Outcome measures

Outcome measures
Measure	Acute Pulmonary Embolism n=5 Participants Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging. 64Cu-FBP8: Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject. PET-CT imaging: All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8.
Overall Clot Burden Within the Lungs TBRmean of the PE	15.07 Unitless ratio Interval 10.86 to 22.35
Overall Clot Burden Within the Lungs TBRmax of the PE	23.23 Unitless ratio Interval 14.05 to 31.66
Overall Clot Burden Within the Lungs SUVmean of the PE	1.420 Unitless ratio Interval 0.708 to 1.743
Overall Clot Burden Within the Lungs SUVmax of the PE	2.098 Unitless ratio Interval 1.497 to 2.499

SECONDARY outcome

Timeframe: 4 hours

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

Outcome measures

Outcome measures
Measure	Acute Pulmonary Embolism n=5 Participants Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging. 64Cu-FBP8: Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject. PET-CT imaging: All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8.
Overall Clot Burden Within the Thigh	0 Unitless ratio Standard Deviation 0

Adverse Events

Acute Pulmonary Embolism

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tilo Winkler

Mass General Hospital

Phone: 617 724-4083

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place