ML-SYS / 2026.07NON-CLINICAL RESEARCH MATERIALSORIGIN DECLARED BY LOT

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RM-DIA / Diagnostic and conjugated peptide agents

Copper Cu 64 Dotatate

Also known as: Detectnet · 64Cu-DOTATATE · Copper oxodotreotide

Approved comparator existsEvidence grade A: Approved comparator exists

Grade describes the published research on the molecule. It is not a quality score, a safety score, or a release state.

What this is

Copper Cu 64 dotatate combines a somatostatin-receptor ligand, DOTA chelator and copper-64 radionuclide. It is a complete radiopharmaceutical identity, not a peptide shorthand.

Evidence position

The regulated diagnostic product and human imaging evidence support Grade A for the labeled agent.

What the record does not establish

The label does not authenticate an unlabelled peptide, another radioisotope or a separately prepared product.

Sources

  • 01
    Detectnet prescribing informationDailyMed / U.S. National Library of Medicine
    Shows
    Current U.S. label for a defined copper-64 dotatate intravenous product
    Does not show
    Does not qualify unlabeled peptide, another isotope, activity or formulation

External database index

LIVE DATABASE INDEX / SEPARATE FROM CURATED EVIDENCE

Records below come directly from public scientific databases. They help find relevant material, but do not affect the evidence grade until they are matched to the molecule and added to the curated source list.

PUBMED / FOUND RECORDS

  1. Copper Cu 64 Dotatate. / 2006PMID 33497164
  2. Pheochromocytomas and paragangliomas.Current opinion in pediatrics / 2021 Aug 1PMID 34039901 / DOI 10.1097/MOP.0000000000001029
  3. Gastro-Entero-Pancreatic Tumors: FDG Positron Emission Tomography/Computed Tomography.PET clinics / 2023 AprPMID 36707371 / DOI 10.1016/j.cpet.2022.11.007
  4. (64)Cu-DOTATATE PET/CT for Imaging Patients with Known or Suspected Somatostatin Receptor-Positive Neuroendocrine Tumors: Results of the First U.S. Prospective, Reader-Masked Clinical Trial.Journal of nuclear medicine : official publication, Society of Nuclear Medicine / 2020 JunPMID 31924723 / DOI 10.2967/jnumed.119.236091
  5. 64Cu-DOTATATE Uptake in a Pulmonary Hamartoma.Clinical nuclear medicine / 2023 Jan 1PMID 36469060 / DOI 10.1097/RLU.0000000000004390

CLINICALTRIALS.GOV / FOUND RECORDS

  1. Dual 64Cu-DOTATATE and 18F-FDG PET/CT Imaging of Patients With Neuroendocrine NeoplasmsUNKNOWN / PHASE2 / Rigshospitalet, DenmarkNCT05709171 / DIRECT intervention MATCH: "64Cu-DOTATATE"
  2. Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATECOMPLETED / PHASE3 / Radiomedix, Inc.NCT03673943 / DIRECT intervention MATCH: "64Cu-DOTATATE"
  3. 64Cu-DOTATATE PET-CT-skanning and Infective Endocarditis.COMPLETED / NA / Emil Loldrup FosbolNCT05432427 / DIRECT intervention MATCH: "64Cu-DOTATATE"
  4. Macrophage PET/CT Imaging Using 64Cu-DOTATATE for the Diagnosis of Cardiac SarcoidosisRECRUITING / NO PHASE / Rigshospitalet, DenmarkNCT06131112 / DIRECT intervention MATCH: "64Cu-DOTATATE"
  5. Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine TumorsRECRUITING / PHASE4 / Vanderbilt-Ingram Cancer CenterNCT06016855 / DIRECT intervention MATCH: Copper Cu 64 Dotatate

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