Recruiting
Phase 1

[64]Cu-Macrin

Sponsor:

Ralph Weissleder, MD

Code:

NCT04843891

Conditions

Sarcoid

Cardiovascular Diseases

Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

[64]Cu Macrin

Study Details

Brief 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.

Conditions

Sarcoid

Cardiovascular Diseases

Cancer

Study ID

NCT04843891

Start date

Sep 6, 2021

Status verified date

Jun, 2022

Completion date

Apr 5, 2023

Anticipated

Primary completion date

Apr 5, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

  • 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

Exclusion Criteria:

  • • 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);
  • 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Healthy Volunteers

In 10 healthy volunteers the radiation dosimetry, normal organ distribution, and safety of \[64Cu\]-Macrin injection will be studied.

experimental: Cardiovascular Disease

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.

experimental: Cancer

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.

experimental: Sarcoidosis

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.

Interventions

[64]Cu Macrin

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

Primary outcome measure

  • To establish human dosimetry of 64Cu Macrin in Healthy Volunteers [ Time Frame: 1 year ]
  • [64Cu] Macrin accumulation and detection in cancer [ Time Frame: 1 year ]
  • [64Cu] Macrin accumulation and detection in myocardial infarction [ Time Frame: 1 year ]
  • [64Cu] Macrin accumulation and detection in sarcoidosis [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Ralph Weissleder, MD, PhD

617-726-8226RWEISSLEDER@PARTNERS.ORG

Aileen O'Shea

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Aileen O'Shea, MD

857-250-9201aoshea1@mgh.harvard.edu

Andrew Lewis, MD

ALEWIS33@mgh.harvard.edu

More Information

Sponsor

Ralph Weissleder, MD

Last update posted

Jun 23, 2022

Last verified

Jun, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ralph Weissleder, MD on 2022-06-23.