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

NCT04843891 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 2021P000355
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (4)

• 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.

  1 year

• [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.

  1 year

• [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.

  1 year

• [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.

  1 year

Secondary Outcomes (1)

• [64Cu] Macrin accuracy for macrophage localization

  1 year

Study Arms (4)

Healthy Volunteers

EXPERIMENTAL

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

Drug: [64]Cu Macrin

Cardiovascular Disease

EXPERIMENTAL

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.

Drug: [64]Cu Macrin

Cancer

EXPERIMENTAL

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.

Drug: [64]Cu Macrin

Sarcoidosis

EXPERIMENTAL

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.

Drug: [64]Cu Macrin

Interventions

[64]Cu Macrin DRUG

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

Cancer; Cardiovascular Disease; Healthy Volunteers; Sarcoidosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ralph Weissleder, MD: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Aileen O'Shea

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Sarcoidosis; Cardiovascular Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology

Model Details: 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

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 14, 2021
• Study Start: September 6, 2021
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)