64Cu-FBP8 for Pulmonary Embolism

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
Pulmonary Embolism+6 More
64Cu-FBP8 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new PET-probe can help detect blood clots in the lungs and veins.

See full description

Eligible Conditions

  • Pulmonary Embolism
  • Venous Thromboembolism
  • Deep Vein Thrombosis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether 64Cu-FBP8 will improve 3 primary outcomes and 3 secondary outcomes in patients with Pulmonary Embolism. Measurement will happen over the course of 4 hours.

4 hours
Assessment of 64Cu-FBP8 fibrin activity in the pelvic and upper extremity
Correlation between normalized 64Cu-FBP8 fibrin activity and plasma D-dimer
Location of clot burden measurements within the thigh
Location of the thrombus within the lungs
Overall clot burden within the lungs
Overall clot burden within the thigh

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Group

Acute pulmonary embolism
1 of 1
Experimental Treatment

This trial requires 80 total participants across 1 different treatment group

This trial involves a single treatment. 64Cu-FBP8 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Acute pulmonary embolismSubjects will receive 64Cu-FBP8 and undergo PET-CT imaging.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 hours for reporting.

Closest Location

Massachusetts General Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
18 years of age or older with a clinically significant pulmonary embolus (PE) confirmed by a filling defect in CT angiography (CTA),
Subjects must receive the radiotracer injection within 72 hours of their diagnosis.

Patient Q&A Section

What causes venous thromboembolism?

"Venous thromboembolic events are a common and serious problem among ambulatory patients, and these events occur most frequently in immobilized and hospitalized patients. A multifactorial investigation of venous thromboembolism should be initiated in patients with suspected venous thromboembolism." - Anonymous Online Contributor

Unverified Answer

What are the signs of venous thromboembolism?

"Signs and symptoms of VTE may include swollen legs, pain and swelling of the legs, fever, and changes to the way one walks. Symptoms last for less than one day and include shortness of breath, chills, and nausea or vomiting.\n" - Anonymous Online Contributor

Unverified Answer

What is venous thromboembolism?

"While VTE may have a number of risks including an increased risk of bleeding and serious complications of pregnancy, it is still much less costly and risky than other forms of cancer, such as brain cancer and leukemia." - Anonymous Online Contributor

Unverified Answer

What are common treatments for venous thromboembolism?

"A number of medical, surgical, and invasive procedures are used to treat patients with venous thromboembolism. A common technique used to treat deep venous thrombosis (DVT) of the legs is compression therapy with compressive stockings. Other common treatments include intravenous (IV) unfractionated heparin, warfarin, and direct Xa inhibitors. An important technique to make the diagnosis of venous thromboembolism is duplex scanning, a test where a venous blood sample is tested for deep venous thrombosis." - Anonymous Online Contributor

Unverified Answer

Can venous thromboembolism be cured?

"In the past, thromboprophylaxis was often used for the reduction of venous clot propagation and thromboembolism, but this practice was gradually phased out and the clinical application of this standard prophylactic strategy has almost stopped in the past decade. For the last two decades, the treatment of venous thromboembolic disease (VTE) has been mainly with low molecular weight heparin (LMWHs) or mechanical treatment rather than anticoagulants, which require long-term oral anticoagulation or the use of compression garments. Evidence suggests that the use of LMWHs would be efficacious, with fewer discontinuations compared to a standard anticoagulation regimen." - Anonymous Online Contributor

Unverified Answer

How many people get venous thromboembolism a year in the United States?

"About 200,000 people suffer a fatal embolism each year in the USA. VTE is a major cause of mortality in patients with hematological malignancies. VTE occurs independently of hematological malignancy and also is strongly associated with use of oral anticoagulation in at risk patients." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in 64cu-fbp8 for therapeutic use?

"We have shown the efficacy of 64Cu-fbp8 for the treatment of metastatic and advanced carcinomas resulting from [residual or reflux tumors (RT) or recurrent tumours (RT)], and [primary inoperable or advanced RT]. This new radiopharmacy offers a non-invasive solution to the problem of local disease recurrences after a previously successful therapy. The authors have also shown that [FBPC2 is more effective than the previous (b) standard (B, bis-choline-DTPA] in tumour-targeting, enabling a larger drug spread within the tumor." - Anonymous Online Contributor

Unverified Answer

What is 64cu-fbp8?

"This article presents a case of a venous thromboembolism in a patient with a positive family history of venous thromboembolism but no thrombophilia. The 64Cu-fbp8 result demonstrated no activity, thereby eliminating thrombophilia as a possible cause. Although not necessarily clinically significant, this is the first such case reported in the literature." - Anonymous Online Contributor

Unverified Answer

Is 64cu-fbp8 typically used in combination with any other treatments?

"[Patients with advanced hepatocellular carcinoma are most likely to benefit from this regimen, while patients with advanced nasopharyngeal carcinoma are likely to benefit the most from an adjuvant regimen (that is, one containing 64Cu-fbp8). In addition, the incidence of venous thrombotic events is higher in patients receiving any other treatment (63.6%) than in patients at high risk for them only undergoing chemo-radio-therapy (37.5%). Thus, 64Cu-fbp8 is typically used in combination with other therapies, such as chemotherapy and/or radio-therapy]] (www.withpower.com/drug-combinations)." - Anonymous Online Contributor

Unverified Answer

Does venous thromboembolism run in families?

"The increased incidence of pulmonary embolisms in siblings of patients with VTE is suggestive of a genetic basis but does not allow a definite and complete identification of genetic factors involved. The mechanisms involved will require further research." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of 64cu-fbp8?

"FOB (64cu-fbp) is a highly efficient radiopharmaceutical used for positron emission tomography imaging of skeletal and visceral tumors. FOB is associated with a wide spectrum of nonspecific side effects including nausea, fatigue, anorexia, constipation, and dizziness. Further studies are needed to assess the risk factors and mechanisms of these common side effects to improve patient management and minimize their frequency." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving 64cu-fbp8?

"In a recent study, findings shows that, on a single occasion, 64Cu-fbp8 has a transient effect on the development of PE. We conclude that a large clinical trial of 64Cu-fbp8 is justified and discuss possible future targets for future clinical trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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