Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-30
Brief Title:
61Cu-NODAGA-LM3 PETCT for the Detection of Neuroendocrine Tumors COPPER PET in NET
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
61Cu-NODAGA-LM3 PETCT for the Detection of Neuroendocrine Tumors The COPPER PET in NET Study A Prospective Open-label Randomized Controlled Single Centre Phase III PETCT Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this monocentric open-label randomized-controlled reader-blind clinical study is to assess the safety of the radiolabeled somatostatin receptor ligand 61Cu-NODAGA-LM3 and its sensitivity in comparison to the standard of care 68Ga-DOTATOC for PETCT imaging in patients with well differentiated bronchopulmonary and gastroenteropancreatic neuroendocrine tumors
Detailed Description:
Neuroendocrine tumors NET originate from neuroendocrine cells and are most commonly found in the gastro-intestinal tract pancreas and lung Many NET grow slowly and are asymptomatic leading to up to 50 being metastatic at diagnosis Overexpression of somatostatin receptor subtype 2 SST2 is a characteristic of NET and presents an important molecular target for the management of these tumors
In Switzerland two radiolabeled somatostatin analogues gallium-68-labeled 68Ga-DOTATOC and 68Ga-DOTATATE are used for SST PETCT imaging of well-differentiated neuroendocrine tumors While these radiolabeled SST agonists provide high clinical performance and can be locally produced they face limitations such as high costs limited production capacity short half-life hindering shipment to smaller centers and high physiological uptake in organs like the liver complicating tumor detection
A novel copper-61 61Cu labeled somatostatin receptor antagonist 61Cu-NODAGA-LM3 shows promise as an imaging agent for SST2 expressing tumors It offers a longer half-life enhanced tumor uptake and retention compared to established radiolabeled SST agonists and improves image contrast
This study aims to compare the safety and sensitivity of 61Cu-NODAGA-LM3 to the standard of care 68Ga-DOTATOC for SST PETCT imaging in patients with well-differentiated bronchopulmonary and gastroenteropancreatic neuroendocrine tumors
The results of the study potentially lead to enhanced diagnostic accuracy and patient care in the management of neuroendocrine tumors
In Switzerland two radiolabeled somatostatin analogues gallium-68-labeled 68Ga-DOTATOC and 68Ga-DOTATATE are used for SST PETCT imaging of well-differentiated neuroendocrine tumors While these radiolabeled SST agonists provide high clinical performance and can be locally produced they face limitations such as high costs limited production capacity short half-life hindering shipment to smaller centers and high physiological uptake in organs like the liver complicating tumor detection
A novel copper-61 61Cu labeled somatostatin receptor antagonist 61Cu-NODAGA-LM3 shows promise as an imaging agent for SST2 expressing tumors It offers a longer half-life enhanced tumor uptake and retention compared to established radiolabeled SST agonists and improves image contrast
This study aims to compare the safety and sensitivity of 61Cu-NODAGA-LM3 to the standard of care 68Ga-DOTATOC for SST PETCT imaging in patients with well-differentiated bronchopulmonary and gastroenteropancreatic neuroendocrine tumors
The results of the study potentially lead to enhanced diagnostic accuracy and patient care in the management of neuroendocrine tumors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None