Trial · NCT04022915
PET Fibrin Imaging of DVT and PE
NCT04022915, Phase 1, Terminated, Peter Caravan; results first posted 2026-03-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PET Fibrin Imaging of DVT and PE. Trials, record NCT04022915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04022915
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PET Fibrin Imaging of DVT and PE
- NCT number
- NCT04022915
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 6 participants, actual
- Lead sponsor
- Peter Caravan
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboembolism
- Interventions
- 64Cu-FBP8, PET-CT imaging
- First posted
- 2019-07-17
- Last updated
- 2026-03-18
- Results first posted
- 2026-03-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Location of the Thrombus Within the Lungs | 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. |
| Primary | Location of Clot Burden Measurements Within the Thigh | 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. |
| Primary | Assessment of 64Cu-FBP8 Fibrin Activity in the Pelvic Veins and Upper Extremity | 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. |
| Secondary | Correlation Between Normalized 64Cu-FBP8 Fibrin Activity and Plasma D-dimer | 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 . |
| Secondary | Overall Clot Burden Within the Lungs | 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) |
| Secondary | Overall Clot Burden Within the Thigh | 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 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Location of the Thrombus Within the Lungs | 72 hours | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Location of Clot Burden Measurements Within the Thigh | 72 hours | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Assessment of 64Cu-FBP8 Fibrin Activity in the Pelvic Veins and Upper Extremity | 4 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Correlation Between Normalized 64Cu-FBP8 Fibrin Activity and Plasma D-dimer | 4 hours | Pearson correlation coefficient | NUMBER | |
| SECONDARY | Overall Clot Burden Within the Lungs | 4 hours | Unitless ratio | MEAN | |
| SECONDARY | Overall Clot Burden Within the Thigh | 4 hours | Unitless ratio | MEAN |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Location of the Thrombus Within the Lungs | Acute Pulmonary Embolism | Blood clots in same left-right lung location in PET and CTPA | 2 | Participants | |
| Location of the Thrombus Within the Lungs | Acute Pulmonary Embolism | 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 | Acute Pulmonary Embolism | No blood clots in PET | 1 | Participants | |
| Location of Clot Burden Measurements Within the Thigh | Acute Pulmonary Embolism | No evidence for clots | 5 | Participants | |
| Location of Clot Burden Measurements Within the Thigh | Acute Pulmonary Embolism | Evidence for clots | 0 | Participants | |
| Assessment of 64Cu-FBP8 Fibrin Activity in the Pelvic Veins and Upper Extremity | Acute Pulmonary Embolism | No evidence for clots | 5 | Participants | |
| Assessment of 64Cu-FBP8 Fibrin Activity in the Pelvic Veins and Upper Extremity | Acute Pulmonary Embolism | Evidence for clots | 0 | Participants | |
| Correlation Between Normalized 64Cu-FBP8 Fibrin Activity and Plasma D-dimer | Acute Pulmonary Embolism | 0 | Pearson correlation coefficient | ||
| Overall Clot Burden Within the Lungs | Acute Pulmonary Embolism | TBRmean of the PE | 15.07 | Full Range 10.86 to 22.35 | Unitless ratio |
| Overall Clot Burden Within the Lungs | Acute Pulmonary Embolism | TBRmax of the PE | 23.23 | Full Range 14.05 to 31.66 | Unitless ratio |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acute Pulmonary Embolism | 6 | |
| Overall Study | COMPLETED | Acute Pulmonary Embolism | 5 | |
| Overall Study | NOT COMPLETED | Acute Pulmonary Embolism | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acute Pulmonary Embolism | 2 | 6 |
| Total, other adverse events | Acute Pulmonary Embolism | 0 | 6 |
| Total, serious adverse events | Acute Pulmonary Embolism | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HL141900 | PET fibrin imaging of DVT and PE | WINKLER, TILO | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2018 to 2021 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04022915
GET https://conductscience.org/api/trials/v1/NCT04022915/registered