Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586047
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Breast Cancer PSMA PET
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of PSMA Expression in Triple Negative Breast Cancer Patients Using 18 F-DCFPyL-PETCT
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to determine the expression of Prostate Specific Membrane AntigenPSMA in metastatic Triple Negative Breast Cancer TNBC patients using Fludeoxyglucose F18 FDG PETCT as the gold standard The investigators hypothesize that most lesions in metastatic TNBC are PSMA-avid and thus PSMA-based radionuclide therapy can be a valid treatment option for TNBC and clinical trials can be designed for this purpose Thirty metastatic TNBC patients will be enrolled and will be on the study for maximum of 4 weeks
Detailed Description:
Prostate Specific Membrane Antigen PSMA is not only expressed in prostate cancer and its metastases but also it is expressed on the neovasculature of many other solid tumors including gastric lung adrenal bladder and renal cell carcinomas Also there is evidence that breast carcinomas express PSMA although this has not been specifically studied in the metastatic TNBC
The study involves a total of 2 visits and on each visit patients will undergo a PET imaging Each patient will first undergo an FDG PETCT and then in few days will undergo an 18F-DCFPyL-PETCT The PET scanner is a large machine with a hollow tube that will be used to see how F18 FDG is taken up into the tumor and other tissues The patients will be asked to lie on the back on a special table that slides into the tube The sides of the tube will be close to the body At the first visit patients will be in this scanner for approximately 20 minutes
The study will evaluate the expression of PSMA via 18 F-DCFPyL-PETCT in metastatic TNBC patients and compare it with lesion detection rate of FDG PETCT PSMA-avid lesions will be detected using the novel agent 18 F-DCFPyL and concordance rate with FDG-avid lesions will be calculated The standardized uptake values SUV of each lesion on both FDG PETCT and 18F-DCFPyL-PETCT will be compared to find a correlation between tumor aggressiveness lesion SUV on FDG PETCT and tumor angiogenesis lesion SUV on 18 F-DCFPyL-PETCT
The study involves a total of 2 visits and on each visit patients will undergo a PET imaging Each patient will first undergo an FDG PETCT and then in few days will undergo an 18F-DCFPyL-PETCT The PET scanner is a large machine with a hollow tube that will be used to see how F18 FDG is taken up into the tumor and other tissues The patients will be asked to lie on the back on a special table that slides into the tube The sides of the tube will be close to the body At the first visit patients will be in this scanner for approximately 20 minutes
The study will evaluate the expression of PSMA via 18 F-DCFPyL-PETCT in metastatic TNBC patients and compare it with lesion detection rate of FDG PETCT PSMA-avid lesions will be detected using the novel agent 18 F-DCFPyL and concordance rate with FDG-avid lesions will be calculated The standardized uptake values SUV of each lesion on both FDG PETCT and 18F-DCFPyL-PETCT will be compared to find a correlation between tumor aggressiveness lesion SUV on FDG PETCT and tumor angiogenesis lesion SUV on 18 F-DCFPyL-PETCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None