Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06502691
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
18FFTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
18FFTT Positron Emission Tomography PET in Patients With Metastatic Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This clinical trial studies how well fluorine F 18 fluorthanatrace 18FFTT positron emission tomography PET works in imaging patients with breast cancer that has spread from where it first started primary site to other places in the body metastatic who are receiving standard of care SOC poly ADP-ribose polymerase PARP inhibitors with or without immune checkpoint inhibitors ICI to be able to detect clinical response to PARP inhibitor ICI treatment 18FFTT is a radiotracer that targets and binds to PARP1 which can potentially be used for the imaging of PARP1 expression using PET Once administered 18FFTT targets and binds to PARP1 Upon PET PARP1-expressing tumor cells can be visualized PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer in the case 18FFTT Because some cancers take up 18FFTT it can be seen with PET PARP inhibitors work as a targeted therapy by blocking an enzyme involved in repairing cell damage It may cause tumor cells to die ICI may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Combining 18FFTT with a PET scan may help detect tumor cells better in patients with metastatic breast cancer who are receiving standard of care PARP inhibitors with our without ICI treatment
Detailed Description:
OUTLINE Patients are assigned to 1 of 2 arms
Arm I Patients receive 18FFTT intravenously IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ICI therapy and again at 12 weeks At least 1-7 days later patients undergo SOC FDG PETcomputed tomography CT and follow up scans at 12 weeks and 6 months Patients may also undergo tissue biopsy during screening and during follow up
Arm II Patients receive 18FFTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ICI therapy At least 1-7 days later patients undergo SOC FDG PETCT and follow up scans at 12 weeks and 6 months Patients may also undergo tissue biopsy during screening
After initial 18FFTT PET imaging patients are followed-up to 6 months or until disease progression
Arm I Patients receive 18FFTT intravenously IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ICI therapy and again at 12 weeks At least 1-7 days later patients undergo SOC FDG PETcomputed tomography CT and follow up scans at 12 weeks and 6 months Patients may also undergo tissue biopsy during screening and during follow up
Arm II Patients receive 18FFTT IV and undergo PET scan 60-75 minutes later on day 1 of initiating SOC PARP inhibitor ICI therapy At least 1-7 days later patients undergo SOC FDG PETCT and follow up scans at 12 weeks and 6 months Patients may also undergo tissue biopsy during screening
After initial 18FFTT PET imaging patients are followed-up to 6 months or until disease progression
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