Copper oxodotreotide Cu-64

Overview

Copper Cu 64 dotatate is a newly approved Cu labeled somatostatin analog and has several advantages over Ga-labeled somatostatin analogs for positron emission tomography (PET). Copper Cu 64 dotatate has a longer half-life and can be produced once a day as opposed to several times a day, and lower positron energy lending to improved spatial resolution. Further studies should be performed to compare the two tracers. Further, PET using Copper Cu 64 dotatate has been found to perform better than the current gold standard of single-photon emission computed tomography (SPECT) using 111In-DTPA-octreotide. In a head-to-head trial, the former tracer detected twice as many lesions as the latter.

Indication

Copper Cu 64 Dotatate is a radiopharmaceutical used with positron emission tomography(PET) to locate somatostatin receptor-positive neuroendocrine tumors.

Associated Conditions

Somatostatin Receptor Positive Neuroendocrine Tumours

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Using Novel Imaging to More Safely Treat Neuroendocrine Tumors	2023/11/08	NCT06122610	Phase 1	Recruiting	University of Wisconsin, Madison
Dual 64Cu-DOTATATE and 18F-FDG PET/CT Imaging of Patients With Neuroendocrine Neoplasms	2023/02/02	NCT05709171	Phase 2	ENROLLING_BY_INVITATION	Rigshospitalet, Denmark
Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE	2018/09/17	NCT03673943	Phase 3	Completed	Radiomedix, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Detectnet	CURIUM US LLC	69945-064	INTRAVENOUS	1.0 mCi in 1 mL	9/14/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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