NCT04843891

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

Status unknown Phase 1 Last updated 23 June 2022

What this trial tests

Phase 1 trial testing [64]Cu Macrin in Sarcoid in 100 participants. Status unknown.

Timeline

6 September 2021

Primary endpoint
5 April 2023

5 April 2023

Quick facts

Lead sponsor	Ralph Weissleder, MD
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	100
Start date	6 September 2021
Primary completion	5 April 2023
Estimated completion	5 April 2023
Sites	2 locations across United States

Drugs / interventions tested

• [64]Cu Macrin — full drug profile →

Conditions studied

• Sarcoid — all drugs for Sarcoid →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Cancer — all drugs for Cancer →

Sponsor

Ralph Weissleder, MD — full company profile →

Who can join

Adults 18 to 80, any sex, with Sarcoid or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dual Immunostimulatory Pathway Agonism through a Synthetic Nanocarrier Triggers Robust Anti-Tumor Immunity in Murine Glioblastoma.
   Lugani S, Halabi EA, Oh J, Kohler RH, et al · · 2023 · cited 31× · PMID 36427266 · DOI 10.1002/adma.202208782
2. "Vascular inflammation and cardiovascular disease: review about the role of PET imaging".
   Sammartino AM, Falco R, Drera A, Dondi F, et al · · 2023 · cited 16× · PMID 36255543 · DOI 10.1007/s10554-022-02730-9
3. Highly Active Myeloid Therapy for Cancer.
   Fredrich IR, Halabi EA, Kohler RH, Ge X, et al · · 2023 · cited 12× · PMID 37824733 · DOI 10.1021/acsnano.3c08034
4. Probing immune infiltration dynamics in cancer by in vivo imaging.
   Ng TSC, Allen HH, Rashidian M, Miller MA. · · 2022 · cited 10× · PMID 35219177 · DOI 10.1016/j.cbpa.2022.102117
5. Advances in Radiopharmaceutical Sciences for Vascular Inflammation Imaging: Focus on Clinical Applications.
   Prigent K, Vigne J. · · 2021 · cited 3× · PMID 34885690 · DOI 10.3390/molecules26237111
6. Host-functionalization of macrin nanoparticles to enable drug loading and control tumor-associated macrophage phenotype.
   Sarkar B, Arlauckas SP, Cuccarese MF, Garris CS, et al · · 2024 · cited 2× · PMID 38545103 · DOI 10.3389/fimmu.2024.1331480
7. <i>CopperNostics</i>-Here We Are Now, Entertain Us!
   Brühlmann SA, Walther M, Kopka K, Kreller M, et al · · 2026 · PMID 41754861 · DOI 10.3390/ph19020321
8. First-in-Human Study of the Carbohydrate Nanoparticle <sup>64</sup>Cu-Macrin.
   O'Shea A, Lewis AJM, Caravan P, Izquierdo-Garcia D, et al · · 2026 · PMID 41469153 · DOI 10.2967/jnumed.125.270770