Pulmonary EmbolismPhase 1NCT04022915
PET Fibrin Imaging of DVT and PE
A Phase 1 study testing 64Cu-FBP8 and PET-CT imaging in people with Pulmonary Embolism and Deep Vein Thrombosis, run by Peter Caravan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboembolism
- What is being tested?
- 64Cu-FBP8 and PET-CT imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2019to 26 Aug 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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).
Read the 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.
- Being tested
- 64Cu-FBP8, PET-CT imaging
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-FBP8Drug
Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject.
PET-CT imagingDiagnostic test
All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8.
| Study group | Role | What they receive |
|---|---|---|
| Acute pulmonary embolism | Experimental | Subjects will receive 64Cu-FBP8 and undergo PET-CT imaging. Receives: Drug: 64Cu-FBP8; Diagnostic Test: PET-CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 hours
Secondary outcomes (3)
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 .
Measured: 4 hours
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:
- 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
- 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
- SUVmean of the PE which is the mean standardized uptake value (SUV) in the pulmonary embolus (clot)
- SUVmax of the PE which is the maximum standardized uptake value (SUV) in the pulmonary embolus (clot)
Measured: 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
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start13 May 2019
- Primary completion19 Jul 2022
- Study completion26 Aug 2024
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects with acute pulmonary embolism meeting the inclusion criteria will be enrolled.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Caravan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Peter Caravan, Massachusetts General Hospital
- Investigators
- Tilo Winkler, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022915
- Sponsor's protocol ID
- 2018P000523
- Other IDs
- R01HL141900
- Status last verified
- Feb 2026
- First submitted
- 10 Jul 2019
- Last updated
- 18 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Fibrin Imaging of DVT and PE
- ClinicalTrials.gov ID
- NCT04022915
- Acronym / sponsor ID
- 2018P000523
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Peter CaravanUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 13 May 2019 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Posted 18 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects with acute pulmonary embolism meeting the inclusion criteria will be enrolled.
| Arm | Type | Receives |
|---|---|---|
| Acute pulmonary embolism | Experimental | Drug: 64Cu-FBP8, Diagnostic Test: PET-CT imagingSubjects will receive 64Cu-FBP8 and undergo PET-CT imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 64Cu-FBP8Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject. | Drug | Acute pulmonary embolism |
| PET-CT imagingAll subjects will undergo PET-CT imaging after administration of 64Cu-FBP8. | Diagnostic test | Acute pulmonary embolism |
Primary outcome
Location of the Thrombus Within the Lungs
Time frame: 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.
Location of Clot Burden Measurements Within the Thigh
Time frame: 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.
Assessment of 64Cu-FBP8 Fibrin Activity in the Pelvic Veins and Upper Extremity
Time frame: 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.
3 secondary outcomes
Correlation Between Normalized 64Cu-FBP8 Fibrin Activity and Plasma D-dimer
Time frame: 4 hours
Overall Clot Burden Within the Lungs
Time frame: 4 hours
Overall Clot Burden Within the Thigh
Time frame: 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tilo Winkler, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 64Cu-FBP8 and PET-CT imaging in people with Pulmonary Embolism and Deep Vein Thrombosis, run by Peter Caravan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Location of the Thrombus Within the Lungs (time frame: 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.