[64Cu]FBP8 for Malignancies

Phase-Based Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
+3 More
[64Cu]FBP8 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Malignancies

Study Summary

This study is evaluating whether a new radiotracer may be useful for detecting thrombosis in the left atrial appendage of patients with atrial fibrillation.

See full description

Eligible Conditions

  • COVID-19
  • Atrial Fibrillation
  • Thrombus
  • Malignancies
  • Thrombosis

Treatment Effectiveness

Study Objectives

This trial is evaluating whether [64Cu]FBP8 will improve 4 primary outcomes in patients with Malignancies. Measurement will happen over the course of 4 hours.

36 hours
Complete blood count
4 hours
Target to Background Ratio
Target to Background Ratio LAA
48 hours
Time activity curve

Trial Safety

Trial Design

5 Treatment Groups

Healthy Volunteers
Other Thrombotic Condition Patients

This trial requires 240 total participants across 5 different treatment groups

This trial involves 5 different treatments. [64Cu]FBP8 is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Other Thrombotic Condition PatientsFifty (50) patients with other thrombotic conditions will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
Cancer PatientsThirty (30) cancer patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
COVID-19 PatientsThirty (30) COVID-19 patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
Atrial Fibrillation PatientsThirty-five (35) patients with LAA thrombus documented by TEE will be injected with [64Cu]FBP8 and imaged for LAA thrombus with MR-PET. The TEE studies in these patients will be part of their routine clinical care. Thirty-five (35) patients with atrial fibrillation and negative TEE will be injected with [64Cu]FBP8 and imaged for LAA thrombus. Forty (40) patients with atrial fibrillation who are scheduled for TEE in the upcoming 14 days will be injected with [64Cu]FBP8 and imaged for LAA thrombus.
Healthy VolunteersTwenty (20) healthy adult subjects will be injected with [64Cu]FBP8 to establish the safety, whole body distribution, metabolism, pharmacokinetics, and radiation burden of the probe. All subjects will be imaged using PET/MR. Healthy subjects will undergo blood collection before, during, and after the scan. Healthy subjects will also undergo electrocardiogram before and after the scan. An interim review of the data will be conducted after the first six subjects receive the study agent and complete all safety assessments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET/MR
2018
Completed Phase 3
~100

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 48 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 48 hours for reporting.

Who is running the study

Principal Investigator
P. C.
Prof. Peter Caravan, Professor of Radiology
Massachusetts General Hospital

Closest Location

Massachusetts General Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Retrospective enrollment: TEE to evaluate LAA within the last 14 days, provided the anticoagulation regimen the patient is on is not changed after the TEE. If a patient has a negative TEE and continues the same stable anti-coagulation regimen he/she is on, then it is extremely unlikely that a new thrombus will develop in the left atrial appendage within the next two weeks. Likewise, if a patient not taking any anti-coagulation has a thrombus in the left atrial appendage, then it is extremely unlikely that this thrombus will resolve spontaneously in the next 14 days if the patient continues not to take any anticoagulation. If the TEE leads to a change being made in the anticoagulation regimen (started/stopped/dose modified), then a time window of 72 hours from the TEE to PET imaging will be used. This scheme will ensure that the TEE can serve as an accurate gold standard;
Positive test for SARS-CoV-2 RNA detected by RT-PCR collected from the upper or lower respiratory tract analyzed by a certified lab with an FDA approved assay within the last month;
Patient not requiring mechanical ventilation;
• Patient is diagnosed with cancer;
Ultrasound- or CT-confirmed or high likelihood of thrombus (e.g. show original
Has not received thrombolytics
You have a history of atrial fibrillation or paroxysmal atrial fibrillation. show original
TEE scheduled in the upcoming 14 days. show original

Patient Q&A Section

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

What are the signs of covid-19?

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Signs of covid-19 infection include fever, cough and shortness of breath (dyspnea). Other signs include headache, muscle aches, and gastrointestinal symptoms with weight loss. There may also be lower limb symptoms such as joint pain and swollen lymph nodes; however, the significance of these symptoms has not been fully established, and in some cases they may go un-investigated. It has been suggested they are most likely to be related to the immune system and to the extent of any underlying illness, and may be associated with a lower-than-average risk of death from covid-19.

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How many people get covid-19 a year in the United States?

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About 700,000 Americans are infected with covid-19 a year. This is an infection far out of proportion to what would be expected given the severity of the disease.

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Can covid-19 be cured?

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Unlike ordinary colds, covid-19 is highly treatable within 1 week/10 days, if patient adherence is good. The severity of illness is largely driven by the underlying disease rather than the virus, and patients who recover, and develop mild disease, do not need further treatment.

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What causes covid-19?

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Covid-19 is a recently emerged infectious disease caused by SARS-CoV-2, a newly described virus that was isolated from bats in China during December 2019. Like others, SARS-CoV-2 can spread easily between people. This has been shown to occur in hospitals even though appropriate precautions are taken. As it is caused by an infectious virus, doctors must take appropriate action to protect themselves, their families, and their patients from exposure. In addition, efforts must be made to educate patients and the general public about the disease and the actions to take as they may be exposed to it.

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What is covid-19?

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After a 3-day national nationwide lockdown beginning March 2019, the government of India has issued the "First Nation-Specific Emergency Order for controlling and prohibiting transmission of, and dealing with, the spread of diseases like COVID-19."\n

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What are common treatments for covid-19?

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The use of vitamin D as a treatment for COVID-19 is not supported by evidence and is, therefore, not recommended. Several clinical guidelines advise against the use of vitamin K for people infected with SARS CoV. Evidence regarding the provision of low-dose vitamin D for people infected with coronavirus-2 does not support a recommendation for routine use. The use of vitamin A for coronavirus-2 is similarly not recommended. There is no evidence to suggest that supplementation of omega-3 polyunsaturated fatty acids, vitamin E, vitamin C, vitamin D, or beta-carotene are useful in adults or children infected with coronavirus-2.

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Does covid-19 run in families?

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As the number of COVID-19 infections continues to increase, these two families with distinct, yet similar epidemiologic histories highlight the need for genetic testing to help identify individuals who may pose a disease transmission concern to close contacts. At present, testing may only identify the symptomatic or those who develop severe infection. These families show that individuals without symptoms in addition to those with severe infection will likely remain undetected by current antibody testing. Such individuals will be overlooked and, if a child catches disease and dies, have contacts of a child whose parents were in close contact with someone who caught the same virus and experienced a symptomatic illness.

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

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(64)Cu-labeled FBP8 has demonstrated in vivo efficacy in murine [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), liver metastases, and primary liver tumors with selectivity for tumor sites. (64)Cu-lbp8 demonstrates promising initial results in people with head/neck cancer and lung cancer. (64)Cu-lbp8 has a high risk for toxicity and thus (64)Cu-lbp8 for therapeutic use warrants further development.

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What is the latest research for covid-19?

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From the results, we can see that the research on the disease is continuously evolving in each area. Many different tests have been established to assist the patient to get the most appropriate treatment for them individually. However, to be helpful for the development of effective treatment strategies, we need new basic information. For example, how does the patient's age plays a role in the effects of the virus. In addition, if we are focusing specifically on [retinal damage] the future needs to be better and we need to look at retinal imaging in patients diagnosed with retinal vascular diseases. This is something the clinician and the laboratory should take into consideration.

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How serious can covid-19 be?

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Serious consequences for some individuals with covid infection are likely but their rate of incidence and lethality can be extremely underestimated because of the asymptomatic nature of the disease.

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Have there been other clinical trials involving [64cu]fbp8?

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We were surprised to find that [64Cu]fenfluramine was safe and efficacious at 2 cm but had minimal clinical improvement. We were also concerned about our ability to deliver the 6-8 mCi of 64Cu to patients. However, after a large dose-escalation study, [Cu]fbp was found to be nontoxic at the dose that had maximum effect.

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What is the primary cause of covid-19?

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Since the virus does not necessarily grow on the wet skin, and high temperature and moisture on skin could also cause the infection, these causes were all considered as possible causes of Covid-19. It is concluded that the virus infection started from the virus shedding from airborne transmission way, and then spread to local micro-clinics and people's hands. This is different from most of the related epidemic infection(such as H1N1 infection, SARS, and MERS) which started from direct contact transmission way in the early stage and then spread to local micro-clinics and people's hands.

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