Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758780
Status:
RECRUITING
Last Update Posted:
2023-02-21
First Post:
2021-01-14
Brief Title:
Imaging Performance Assessment of 89Zirconium-labelled Girentuximab 89Zr-TLX250 PET-CT in Metastatic Triple Negative Breast Cancer Patients
Sponsor:
Institut Cancerologie de lOuest
Organization:
Institut Cancerologie de lOuest
Study Overview
Official Title:
Prospective Phase II Pilot Study Assessing Imaging Performance of 89Zirconium-labelled Girentuximab 89Zr-TLX250 PET-CT Positron Emission TomographyComputerized Tomography in Metastatic Triple Negative Breast Cancer Patients
Status:
RECRUITING
Status Verified Date:
2023-02
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:
OPALESCENCE
Brief Summary:
The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab 89Zr-TLX250 as a novel carbonic anhydrase IX CAIX targeted PETCT tracer for the imaging of metastatic triple negative breast cancer TNBC patients
Detailed Description:
The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab 89Zr-TLX250 as a novel Carbonic Anhydrase IX CAIX targeted PETCT tracer for the imaging of metastatic triple negative breast cancer TNBC patients
TNBC patients are known to be rapidly progressive and have a poor prognosis This poor prognosis is due to the lack of common breast cancer targets in TNBC As TNBC expresses CAIX this stuy will evaluate CAIX targeting by using a radiolabeled monoclonal antibody that recognizes carbonic anhydrase IX CAIX 89Zr- girentuximab otherwise known as 89Zr-TLX250 Previous and ongoing studies have demonstrated the potential application of 89Zr-TLX250 as a new PETCT imaging tracer for the detection of renal cancer
After establishing the TNBC targeting properties of the 89Zr-TLX250 PETCT imaging tracer it should be interesting to develop a new targeted therapy using TLX250- radiolabeled with a therapeutic radionuclide such as 177Lutétium
TNBC patients are known to be rapidly progressive and have a poor prognosis This poor prognosis is due to the lack of common breast cancer targets in TNBC As TNBC expresses CAIX this stuy will evaluate CAIX targeting by using a radiolabeled monoclonal antibody that recognizes carbonic anhydrase IX CAIX 89Zr- girentuximab otherwise known as 89Zr-TLX250 Previous and ongoing studies have demonstrated the potential application of 89Zr-TLX250 as a new PETCT imaging tracer for the detection of renal cancer
After establishing the TNBC targeting properties of the 89Zr-TLX250 PETCT imaging tracer it should be interesting to develop a new targeted therapy using TLX250- radiolabeled with a therapeutic radionuclide such as 177Lutétium
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