[64]Cu Macrin for Sarcoidosis

1
Effectiveness
1
Safety
Aileen O'Shea, Boston, MA
Sarcoidosis+2 More
[64]Cu Macrin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Sarcoidosis

Study Summary

This study is evaluating whether a radioactive drug may be useful for imaging certain diseases.

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Eligible Conditions

  • Sarcoidosis
  • Cardiovascular Diseases
  • Malignancies

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether [64]Cu Macrin will improve 4 primary outcomes and 1 secondary outcome in patients with Sarcoidosis. Measurement will happen over the course of 1 year.

1 year
To establish human dosimetry of 64Cu Macrin in Healthy Volunteers
[64Cu] Macrin accumulation and detection in cancer
[64Cu] Macrin accumulation and detection in myocardial infarction
[64Cu] Macrin accumulation and detection in sarcoidosis
[64Cu] Macrin accuracy for macrophage localization

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

No Control Group
Healthy Volunteers

This trial requires 100 total participants across 4 different treatment groups

This trial involves 4 different treatments. [64]Cu Macrin 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.

Healthy Volunteers
Drug
In 10 healthy volunteers the radiation dosimetry, normal organ distribution, and safety of [64Cu]-Macrin injection will be studied.
Sarcoidosis
Drug
In 30 subjects with sarcoidosis the radiation dosimetry, normal organ distribution, and safety of [64Cu]-Macrin injection will be studied. In addition, the ability of [64Cu] Macrin to concentrate at the tumor site will be correlated with imaging and histopathology, where available.
Cardiovascular Disease
Drug
In 30 subjects with a history of recent myocardial infarct, the radiation dosimetry, normal organ distribution, and safety of [64Cu]-Macrin injection will be studied. In addition, the ability of [64Cu] Macrin to concentrate at the infarct site will be correlated with cardiac MRI.
Cancer
Drug
In 30 subjects with an epithelial malignancy the radiation dosimetry, normal organ distribution, and safety of [64Cu]-Macrin injection will be studied. In addition, the ability of [64Cu] Macrin to concentrate at the tumor site will be correlated with imaging and histopathology, where available.

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: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Aileen O'Shea - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Group 2: Patients with Alzheimer's disease Group 1 is composed of healthy subjects show original
Physician investigators or nurse practitioners will assess the health of potential participants at the screening visit show original
"Have the ability to agree to or refuse medical treatment in writing. show original
to purchase The text means that you have to be 18 years or older in order to purchase something. show original
Be able to write and understand information about the study. show original
Group 2: Myocardial Infarction
Group 3: Sarcoidosis
No known history of pre-existing cardiac or respiratory disease or malignancy
The first reported percutaneous coronary intervention was in 1967, when a stent was used to open a blocked coronary artery in a patient with acute coronary syndrome show original
Hemodynamically stable

Patient Q&A Section

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

Does sarcoidosis run in families?

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Results from a recent paper and previously published data indicate a strong genetic basis of sarcoidosis which needs to be further investigated to identify genetic susceptibility factors and, eventually, new therapeutic approaches for Sarcoidosis.

Unverified Answer

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

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The [64]Cu macrin inactivation of the NADPH oxidase enzyme activity appears to be feasible in human monocytes. [64]Cu macrin is therefore a potential alternative for treatment of atherosclerotic plaque inflammation caused by reactive oxygen species and has the potential of detecting and treating cardiovascular diseases, especially when co-administered with statins. The [64]Cu macrin is not a good substitute to the natural macrin in the treatment of sarcoidosis. The [64]Cu macrin appears to be a good alternative to the natural macrin for detection and treatment of sarcoidosis.

Unverified Answer

What is sarcoidosis?

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The pathogenesis of sarcoidosis remains unknown and remains a field of active research. Sarcoidosis has a peak incidence around the age of 30, and is relatively common among Asians. Most patients with sarcoidosis have a benign self-limited course and do not require long-term treatment. However, a minority of patients develop complications and require long-term corticosteroid therapy. Approximately 20% of the patients with sarcoidosis develop lung infiltrates. These lesions are composed of epithelioid cells, giant cells, and small arteries, plexuses of small arteries, plexiform nodules, and lymph nodes.

Unverified Answer

How many people get sarcoidosis a year in the United States?

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Approximately 18.1 million Americans have a case of sarcoidosis each year. In this group, women are more likely to get sarcoidosis than men are. Approximately 1 in 4 sarcoidosis patients will develop lung disease, but the overall mortality rate is not higher in sarcoidosis as compared to the general population. We estimate that up to 1,800 people die from sarcoidosis each year in the United States. Findings from a recent study suggest sarcoidosis is less frequent than previously thought.

Unverified Answer

What are common treatments for sarcoidosis?

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The disease may respond or resolve to many treatments; however, the specifics depend on the type of response. Some patients do not respond to all treatments; therefore, we consider individual treatments as part of a comprehensive therapy and not as an individual treatment for every possible symptom. There are no 'cures' for sarcoidosis.\n

Unverified Answer

What are the signs of sarcoidosis?

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The signs of sarcoidosis are not very specific, but if these signs are present then the diagnosis of sarcoidosis is strongly suspected. Some of the symptoms may be due to lung cancer. For any particular sign, the probability of it being caused by sarcoidosis may vary from person to person, especially with the age and sex of the person (e.g., menopause in women). There are many other symptoms that are not specific to sarcoidosis and have a range of possible causes.

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Can sarcoidosis be cured?

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Without treatment, the average life expectancy of sarcoidosis patients is 13-15 years. Survival depends on the stage and the disease duration. Sarcoidosis should be considered a lifelong condition. Treatment has a high cure rate (90-99%) for localized disease.

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What causes sarcoidosis?

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The etiology of sarcoidosis is not fully understood, but it is believed to result from a combination of environmental and genetic factors. The most common environmental risk factor is exposure to inhaled antigenic materials such as inhaled bacteria or fungi (parasites, pollen, molds), as well as some chemical toxins. Smoking is a probable genetic risk factor for sarcoidosis. The role for cigarette smoke exposure is not well delineated at present; however, most studies from around the world report that tobacco smoke is the main etiologic agent.

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Is [64]cu macrin safe for people?

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A prospective, single dose, randomized, double blind crossover study of a large dose of 0.025 M 64Cu-macrin showed excellent radiation dosimetry in patients with a mean ED of approximately 7 kRa*h/kg over the whole body, resulting in no adverse effects. The study demonstrates the safety of high dose radiation therapy for treatment of sarcoidosis in children and teenagers.

Unverified Answer

What does [64]cu macrin usually treat?

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What type of sarcoidosis does CuMac treatment work well with? answer: The type of sarcoidosis, but not its stage, seemed to predict which type of treatment is best, both in terms of its efficacy and its toxicity. It also seemed that the dosage and time intervals needed did not vary by the type of sarcoidosis. This was more so when patients were treated in a high quality center than when they were referred to a low quality center. However, some sarcoidosis patients could not get optimal treatment under both settings.

Unverified Answer

What is the primary cause of sarcoidosis?

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Given that a small percentage of sarcoidosis cases are familial, it seems likely that a variety of etiologies of sarcoidosis can exist. It is thought that, in conjunction with environmental factors, specific genetic and environmental factors may act in synergistic or sequential ways to exacerbate a preexisting T-cell disorder that had a common etiology with sarcoidosis, causing the development of sarcoidosis.

Unverified Answer

Who should consider clinical trials for sarcoidosis?

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With experience, clinical trials may be helpful in the management of sarcoidosis. However, the number of participants who would benefit from a trial and the possibility of improving outcomes with a trial are low. Further research is indicated concerning the optimal therapy and its timing, as well as the optimal use of biological agents.

Unverified Answer
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