Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413355
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-09
Brief Title:
FAPI-74 PETCT in Adults with Fibrosis
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
Fibroblast Activating Protein FAP PETCT in Adults with Fibrotic Conditions
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This protocol is intended as a basket protocol designed to evaluate the use of Fibroblast Activating Protein FAP PETCT in imaging the presence of fibrosis caused by a variety of medical conditions where fibrosis is believed to lead to pathological effects and poor prognosis
Detailed Description:
A study to evaluate subjects with fibrosis-inducing medical conditions that are known or suspected to cause tissue fibrosis eg cancer-associated post-infection post-radiation pre or post-transplant cardiac liver kidney or pulmonary fibrosis This protocol is intended to expand as needed with imaging arms designed to evaluate the use of Fibroblast Activating Protein FAP PET CT in imaging the presence fibrosis caused by medical conditions where fibrosis is believed to lead to pathological effects and poor prognosis
18F-FAPI-74 is a positron emitting radiolabeled FAP inhibitor that will be used with a positron emission tomographycomputed tomography PETCT scan that will be completed in each subject who has a clinical suspicion of fibrotic disease
PETCT imaging will be used to evaluate the distribution of fibroblast activating protein FAP in major organs and other tissues affected with fibrotic diseases or conditions This is an observational study in that F-18-FAPI-74 PETCT will not be used to direct treatment decisions While patients and referring physicians will not be blinded to the F-18-FAPI-74 PETCT results any medical or treatment decisions related to their underlying clinical diagnosis will be made by the treating physicians based upon clinical criteria
After injection of F-18-FAPI-74 patients will undergo a vertex to mid-thigh scan starting at approximately 60 minutes post injection PETCT imaging sessions will include an injection of approximately 80 mCi expected range of doses is expected to be 60-80 mCi of F-18-FAPI-74 intravenously Data will be collected to evaluate uptake of F-18-FAPI-74 in sites of suspected fibrosis and in major organs
An optional second PETCT using F-18-FAPI-74 can be considered at the request of the investigators at any clinically relevant time point This second scan may be used to quantify the changes in fibrosis over time as part of the natural progression of the fibrotic condition or to observe changes in F-18- FAPI-74 uptake in response to therapeutic interventions
18F-FAPI-74 is a positron emitting radiolabeled FAP inhibitor that will be used with a positron emission tomographycomputed tomography PETCT scan that will be completed in each subject who has a clinical suspicion of fibrotic disease
PETCT imaging will be used to evaluate the distribution of fibroblast activating protein FAP in major organs and other tissues affected with fibrotic diseases or conditions This is an observational study in that F-18-FAPI-74 PETCT will not be used to direct treatment decisions While patients and referring physicians will not be blinded to the F-18-FAPI-74 PETCT results any medical or treatment decisions related to their underlying clinical diagnosis will be made by the treating physicians based upon clinical criteria
After injection of F-18-FAPI-74 patients will undergo a vertex to mid-thigh scan starting at approximately 60 minutes post injection PETCT imaging sessions will include an injection of approximately 80 mCi expected range of doses is expected to be 60-80 mCi of F-18-FAPI-74 intravenously Data will be collected to evaluate uptake of F-18-FAPI-74 in sites of suspected fibrosis and in major organs
An optional second PETCT using F-18-FAPI-74 can be considered at the request of the investigators at any clinically relevant time point This second scan may be used to quantify the changes in fibrosis over time as part of the natural progression of the fibrotic condition or to observe changes in F-18- FAPI-74 uptake in response to therapeutic interventions
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?:
None
Is an FDA AA801 Violation?:
None