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SarcoidPhase 1NCT04843891

Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.

A Phase 1 study testing [64]Cu Macrin in people with Sarcoid and Cardiovascular Diseases, run by Ralph Weissleder, MD at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the safety of [64Cu] Macrin and its whole-body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers. To detect [64Cu]-Macrin accumulation in sites of disease in subjects with cancer, sarcoidosis or myocardial infarct. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Sarcoid, Cardiovascular Diseases, Cancer
What is being tested?
[64]Cu Macrin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesUnited States
Study dates
6 Sep 2021to 5 Apr 2023
Phase
Phase 1
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Group 1: Healthy subjects
  • Must be 18 years of age or older
  • Must be deemed healthy at screening visit, as determined by the physician investigator or nurse practitioner, based on the following assessments at screening: physical examination, medical history and vital signs;
  • No known history of pre-existing cardiac or respiratory disease or malignancy
  • Have the ability to give written informed consent.
  • Group 2: Myocardial Infarction
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  • History of percutaneous coronary intervention (PCI) for acute or chronic coronary syndrome (within 3-5 days)
  • Have the ability to give written informed consent
  • Must be 18 years of age or older
  • Hemodynamically stable
  • Group 3: Sarcoidosis
  • A suspected or confirmed diagnosis of intrathoracic sarcoidosis
  • Have the ability to give written informed consent
  • Must be 18 years of age or older
  • Group 4: Malignancy
  • Suspected or confirmed thoracic, intra-abdominal or pelvic malignancy
  • Have the ability to give written informed consent
  • Must be 18 years of age or older

Who cannot join

  • • Electrical implants, such as cardiac pacemaker or perfusion pump;
  • Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing;
  • eGFR of less than 30 mL/min/1.73 m2 within the past 30 days;
  • Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate);
  • Self-reported or documented claustrophobic reactions;
  • Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
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  • Unable to lie comfortably on a bed inside the MR-PET;
  • BMI > 33 (limit of the PET-MRI table);
  • Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures);
  • Stroke within the last 3 months;
  • Cardiac or major surgery within the last 3 months;
  • History of abnormal heart rate including persistent tachyarrhythmia (heart rate persistently >120 bpm) or bradyarrhythmia (heart rate persistently < 50 bpm);
  • History of atrial premature complexes with daytime pauses > 3s;
  • Contraindications to gadolinium-based contrast agents, including an eGFR < 30 mL/min (myocardial infarction and sarcoidosis patients only).
  • History of myeloproliferative disorder.
  • Age >80 years.

Trial locations and contacts

2 sites in 1 country.

United States2 sites, 2 recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Ralph Weissleder, MD, PhD, 617-726-8226, RWEISSLEDER@PARTNERS.ORG

    Recruiting

  • Aileen O'Shea

    Boston, Massachusetts, 02115

    Aileen O'Shea, MD, 857-250-9201, aoshea1@mgh.harvard.edu

    Andrew Lewis, MD, ALEWIS33@mgh.harvard.edu

    Recruiting

Other trials in United States

About this study

Official title: Preliminary Evaluation of [64Cu] Macrin in Healthy Individuals and Subjects With Cardiovascular Disease, Sarcoidosis and Malignancy.

To evaluate the safety of [64Cu] Macrin and its whole-body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers. To detect [64Cu]-Macrin accumulation in sites of disease in subjects with cancer, sarcoidosis or myocardial infarct.

Read the detailed description

Macrophages are phagocytic cells of the innate immune system. Their accumulation is a hallmark of many inflammatory diseases and they have diverse roles in tissue responses to infection and injury and in tissue repair. As macrophages have a tissue specific and often disease stage specific roles, future therapies directed at macrophage subtypes at certain points in the course of a disease may be more efficacious and result in less systemic side effects, as compared to conventional chemotherapeutics. [64Cu] Macrin is designed to detect macrophages by PET imaging. As a result, PET imaging can be used to identify inflammatory "hotspots" and quantitate local macrophage density non-invasively. The investigators studies in mice showed that [64Cu] Macrin has excellent pharmacological and pharmacokinetic profile with high target uptake and low retention in background tissues and organs.

The investigators wish to first evaluate in healthy human subjects the pharmacological and pharmacokinetic profile, and the overall safety of the new radiopharmaceutical [64Cu] Macrin. The investigators will then establish the concentration of [64Cu] Macrin in patients following myocardial infarct, in sarcoidosis and in cancer patients. In a subset of patients where tissue sampling is feasible, we will correlate tracer uptake on imaging to macrophage density on histopathology or with additional standard of care imaging studies.

Being tested
[64]Cu Macrin
Medical subject headings
Sarcoidosis, Cardiovascular Diseases, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [64]Cu MacrinDrug

    Up to 15 mCi of [68Ga]CBP8 will be administered to each subject.

Study groups in NCT04843891
Study groupRoleWhat they receive
Healthy VolunteersExperimentalIn 10 healthy volunteers the radiation dosimetry, normal organ distribution, and safety of [64Cu]-Macrin injection will be studied.
Receives: Drug: [64]Cu Macrin
Cardiovascular DiseaseExperimentalIn 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.
Receives: Drug: [64]Cu Macrin
CancerExperimentalIn 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.
Receives: Drug: [64]Cu Macrin
SarcoidosisExperimentalIn 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.
Receives: Drug: [64]Cu Macrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To establish human dosimetry of 64Cu Macrin in Healthy Volunteers

    We will use established methods to provide quantitative information on the amount of [64Cu] Macrin radioactivity that accumulates in peripheral organs and brain. Dose-corrected imaging data will be processed using time-activity curves based on ROIs manually-drawn on MR data and projected onto PET datasets.

    Measured: 1 year

  2. [64Cu] Macrin accumulation and detection in cancer

    Probe uptake will be measured in organs affected by solid epithelial malignancies and compared to uptake in the uninvolved parts of the organs and in these organs in healthy volunteers. We expect greater uptake in the part of the organs affected by malignancy.

    Measured: 1 year

  3. [64Cu] Macrin accumulation and detection in myocardial infarction

    Probe uptake will be measured at a myocardial infarct and compared to uptake in the remainder of the heart and in the hearts of healthy volunteers. We expect greater uptake at the site of a myocardial infarction.

    Measured: 1 year

  4. [64Cu] Macrin accumulation and detection in sarcoidosis

    Probe uptake will be measured in the heart and lungs of patients with sarcoidosis and compared to uptake in these organs in healthy volunteers. We expect greater uptake in the organs affected by sarcoidosis.

    Measured: 1 year

Secondary outcomes (1)

  1. [64Cu] Macrin accuracy for macrophage localization

    To determine the sensitivity and specificity of [64 Cu] Macrin accumulation for the detection at sites of inflammation by comparing tracer accumulation to histopathology and/or standard of care imaging studies

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2021
  2. Study start6 Sep 2021
  3. Primary completion5 Apr 2023 (estimated)
  4. Study completion5 Apr 2023 (estimated)

Resources

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
Non-randomised
Intervention model
Single group
Model description
Eligible subjects, including healthy volunteers and patients with sarcoidosis, cardiovascular disease and cancer, will be enrolled to undergo imaging with the PET Probe \[64\]Cu Macrin
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04843891
Sponsor's protocol ID
2021P000355
Status last verified
Jun 2022
First submitted
31 Mar 2021
Last updated
23 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • O'Shea A, Lewis AJM, Caravan P, Izquierdo-Garcia D, Le Fur M, Catalano OA, Montesi SB, Quintana JM, Carlson JCT, Dubach JM, Castro CM, Bobic M, Huesa-Berral C, Ng TSC, Bertolet A, Nahrendorf M, Weissleder R. First-in-Human Study of the Carbohydrate Nanoparticle 64Cu-Macrin. J Nucl Med. 2026 Mar 2;67(3):449-455. doi: 10.2967/jnumed.125.270770.

    PubMed 41469153

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [64]Cu Macrin in people with Sarcoid and Cardiovascular Diseases, run by Ralph Weissleder, MD at 2 sites 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 18 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To establish human dosimetry of 64Cu Macrin in Healthy Volunteers (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04843891, which also lists 1 linked publication.

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 23 Jun 2022.

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