Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099093
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2023-10-19
Brief Title:
Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
A Pilot Study of 18F-DCFPyL-PSMA PET in Patients Receiving 177Lu-Vipivotide Tetraxetan Therapy for Metastatic Castrate-resistant Prostate Cancer
Status:
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 purpose of this research study is to see how well an imaging test called 18FDCFPyL prostate specific membrane antigen PSMA positron emission tomography PET can show the extent of prostate cancer when comparing to 68Ga-PSMA-11 PETCT another type of diagnostic scan for prostate cancer
Detailed Description:
This is a one-arm single-stage prospective pilot study to determine how 18F-DCFPyL PSMA-PETCT can be used as a diagnostic test before treatment with 177Lu-vipivotide tetraxetan which is an approved therapy for advanced prostate cancer
The US Food and Drug Administration FDA has approved 18F-DCFPyL as a diagnostic agent radiotracer option for prostate cancer though it is not specifically approved for participants who are due to receive 177Lu-vipivotide tetraxetan therapy
This research study involves a single PET scan using the imaging agent 18F-DCFPyL and the collection of information from medical records
Participation in this research study is expected to last about 12 months
It is expected that about 30 people will take part in this research study Progenics Pharmaceuticals Inc is funding this research study by providing funding and the imaging agent 18F-DCFPyL
The US Food and Drug Administration FDA has approved 18F-DCFPyL as a diagnostic agent radiotracer option for prostate cancer though it is not specifically approved for participants who are due to receive 177Lu-vipivotide tetraxetan therapy
This research study involves a single PET scan using the imaging agent 18F-DCFPyL and the collection of information from medical records
Participation in this research study is expected to last about 12 months
It is expected that about 30 people will take part in this research study Progenics Pharmaceuticals Inc is funding this research study by providing funding and the imaging agent 18F-DCFPyL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None