Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT04457258
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-12
First Post:
2020-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Sarcoma: An Exploratory Biodistribution Study With Histopathology Validation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
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 early phase I trial studies an imaging technique called 68Ga-FAPi-46 PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with sarcoma. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-FAPi. Because some cancers take up 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body.
Detailed Description:
PRIMARY OBJECTIVE:
I. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with sarcoma with histopathology validation.
SECONDARY OBJECTIVES:
I. To evaluate whether 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) reflects geography, extent and degree of FAP expression determined by immuno-histochemistry (IHC).
II. To assess the 68Ga-FAPI-46 biodistribution correlation with fludeoxyglucose F-18 (18F-FDG) biodistribution and to define the frequency of the following phenotypes (FAP positive \[+\]/ FDG+, FAP negative \[-\]/ FDG+, FAP+/ FDG-, FAP-/ FDG-).
III. 3. To determine FAP expression profile and identify activating and loss of function mutations and gene rearrangement in available tumor tissue samples from patients with localized or metastatic sarcoma using RNA sequencing
OUTLINE:
Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).
I. To define the biodistribution of gallium Ga 68 fibroblast activation protein inhibitor (FAPi)-46 (68Ga-FAPi-46) in normal and cancer tissues of patients with sarcoma with histopathology validation.
SECONDARY OBJECTIVES:
I. To evaluate whether 68Ga-FAPi-46 accumulation observed by positron emission tomography (PET) reflects geography, extent and degree of FAP expression determined by immuno-histochemistry (IHC).
II. To assess the 68Ga-FAPI-46 biodistribution correlation with fludeoxyglucose F-18 (18F-FDG) biodistribution and to define the frequency of the following phenotypes (FAP positive \[+\]/ FDG+, FAP negative \[-\]/ FDG+, FAP+/ FDG-, FAP-/ FDG-).
III. 3. To determine FAP expression profile and identify activating and loss of function mutations and gene rearrangement in available tumor tissue samples from patients with localized or metastatic sarcoma using RNA sequencing
OUTLINE:
Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).
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?: