Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-03-09 @ 2:43 PM
Study NCT ID:
NCT04457232
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-15
First Post:
2020-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Prostate Cancer: A Prospective Exploratory Biodistribution Study With Histopathology Validation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
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:
FAPI PET Prost
Brief Summary:
This exploratory study investigates how a new imaging technique called FAPI PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with prostate cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers including prostate cancer.
Detailed Description:
PRIMARY OBJECTIVE:
I. To define the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer.
SECONDARY OBJECTIVES:
I. To evaluate whether 68Ga-FAPi-46 and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) accumulation observed by positron emission tomography (PET) correlates with the amount of fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) in excised cancer tissue, respectively.
II. To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11.
OUTLINE:
Patients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/computed tomography (CT) imaging over 20-50 minutes.
I. To define the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer.
SECONDARY OBJECTIVES:
I. To evaluate whether 68Ga-FAPi-46 and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) accumulation observed by positron emission tomography (PET) correlates with the amount of fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) in excised cancer tissue, respectively.
II. To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11.
OUTLINE:
Patients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/computed tomography (CT) imaging over 20-50 minutes.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: