Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503146
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
18F-Fibroblast Activation Protein Inhibitor 18FFAPI-74 PET Imaging for Cancer Detection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
18F-Fibroblast Activation Protein Inhibitor 18FFAPI-74 PET Imaging for Cancer Detection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09-26
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:
Background
Fibroblast-activation protein FAP is an enzyme that appears in high numbers in certain cancer cells 18FFAPI-74 is a new tracer-a substance that is injected into a person s body before an imaging scan Researchers believe that 18FFAPI-74 may be able to highlight FAP enzymes more effectively than approved tracers If so the new tracer would make it easier to find FAP-positive tumors in the body
Objective
To see if 18FFAPI-74 PET scans are as good or better than other methods for detecting certain cancers
Eligibility
People aged 18 years or older with cancer in 1 of these places the ducts of the pancreas liver gallbladder or small intestine stomach bladder ovaries or adrenal glands They must be enrolled in an NIH treatment study for their cancer
Design
Participants will have 2 baseline scans 1 with 18FFAPI-74 1 with an approved tracer
The 18FFAPI-74 will be infused through a tube attached to a needle inserted into a vein About 1 hour later the participant will undergo 1 or more imaging scans
Within 1 week participants will undergo the same scanning procedures with the approved tracer
If the baseline scan with 18FFAPI-74 shows the tumors scans with this tracer will be repeated when their regular treatment regimen calls for scans again If the scans with the regular tracer also showed tumors this scan will be repeated within the same week as the repeated 18FFAPI-74 scans If either type of scan showed no tumors that scan will not be repeated
If the participant s cancer progresses within 2 years both types of scan may be repeated
Follow-up calls will continue for 2 years
Fibroblast-activation protein FAP is an enzyme that appears in high numbers in certain cancer cells 18FFAPI-74 is a new tracer-a substance that is injected into a person s body before an imaging scan Researchers believe that 18FFAPI-74 may be able to highlight FAP enzymes more effectively than approved tracers If so the new tracer would make it easier to find FAP-positive tumors in the body
Objective
To see if 18FFAPI-74 PET scans are as good or better than other methods for detecting certain cancers
Eligibility
People aged 18 years or older with cancer in 1 of these places the ducts of the pancreas liver gallbladder or small intestine stomach bladder ovaries or adrenal glands They must be enrolled in an NIH treatment study for their cancer
Design
Participants will have 2 baseline scans 1 with 18FFAPI-74 1 with an approved tracer
The 18FFAPI-74 will be infused through a tube attached to a needle inserted into a vein About 1 hour later the participant will undergo 1 or more imaging scans
Within 1 week participants will undergo the same scanning procedures with the approved tracer
If the baseline scan with 18FFAPI-74 shows the tumors scans with this tracer will be repeated when their regular treatment regimen calls for scans again If the scans with the regular tracer also showed tumors this scan will be repeated within the same week as the repeated 18FFAPI-74 scans If either type of scan showed no tumors that scan will not be repeated
If the participant s cancer progresses within 2 years both types of scan may be repeated
Follow-up calls will continue for 2 years
Detailed Description:
Background
Fibroblast-activation protein FAP is a transmembrane type 2 serine protease with dipeptidyl peptidase and endopeptidase activity that is overexpressed on the surface of cancer-associated fibroblasts CAFs a major constituent of the tumor stroma which correlates with a poor prognosis
FAP-positive CAFs are present in the stromal tissue of more than 90 of epithelial carcinomas including pancreatic colorectal ovarian lung and breast cancer among others
FAP has emerged in recent years as a promising target for molecular imaging with PETComputed Tomography CT using radiolabeled FAP inhibitors FAPI FAPI labeled with 68Ga or 18F has shown great promise in cancer detection demonstrating high tumor-to-background ratios in patients across a wide array of cancers
While there is much clinical data with 68Ga-FAPI there is much less data on the efficacy of 18FFAPI-74 which is a more practical version of this PET agent due to its longer half-life
Objective
-To compare 18FFAPI-74 PET imaging to 18F-fluorodeoxyglucose 18F-FDG PET imaging and other imaging considered standard of care SOC eg CT andor magnetic resonance imaging MRI to detect sites of cancer in several malignancies
Eligibility
18 years old
Histologically confirmed pancreatic ductal adenocarcinoma PDAC cholangiocarcinoma hepatocellular carcinoma HCC gastric cancer bladder cancer ovarian cancer or pheochromocytoma
Participants must be co-enrolled in an NIH parent cancer treatment clinical trial with the planned evaluation of response per Response Evaluation Criteria in Solid Tumors RECIST v11 and other imaging considered SOC
Eastern Cooperative Oncology Group ECOG Performance score 2
Design
This is a single-site imaging study enrolling participants with PDAC cholangiocarcinoma HCC gastric cancer bladder cancer ovarian cancer or pheochromocytoma With 25 x 7 175 evaluable participants needed we will plan for a small number of inevaluable participants 35 intending to initiate intervention in up to 210 participants Note To allow for screen failures a total of 220 will be set for the purposes of the NIH accrual ceiling
All participants will undergo baseline 18FFAPI-74 PET and 18F-FDG PET imaging
Participants with a positive baseline 18FFAPI-74 PET scan ie with the presence of FAPIpositive tumors will undergo the second 18FFAPI-74 PET imaging at the time of the next re-staging performed on the parent treatment protocol Participants with a negative baseline 18FFAPI-74 PET scan will not have post-treatment 18FFAPI-74 PET or 18F-FDG PET scans performed on this protocol but will remain in follow-up
Participants with a negative baseline 18F-FDG PET scan will not be re-scanned with 18F-FDG PET but may be re-scanned with 18FFAPI-74 PET if baseline 18FFAPI-74 PET imaging is positive
All participants will be followed for 2 years following the first 18FFAPI-74 PET scan to assess progression-free survival and 2-year overall survival During this period participants may undergo the additional 18FFAPI-74 and 18F-FDG PET imaging in case of suspicion for recurrencedisease progression These scans may be done even if the baseline 18FFAPI-74 andor 18F-FDG PET imaging are negative
Fibroblast-activation protein FAP is a transmembrane type 2 serine protease with dipeptidyl peptidase and endopeptidase activity that is overexpressed on the surface of cancer-associated fibroblasts CAFs a major constituent of the tumor stroma which correlates with a poor prognosis
FAP-positive CAFs are present in the stromal tissue of more than 90 of epithelial carcinomas including pancreatic colorectal ovarian lung and breast cancer among others
FAP has emerged in recent years as a promising target for molecular imaging with PETComputed Tomography CT using radiolabeled FAP inhibitors FAPI FAPI labeled with 68Ga or 18F has shown great promise in cancer detection demonstrating high tumor-to-background ratios in patients across a wide array of cancers
While there is much clinical data with 68Ga-FAPI there is much less data on the efficacy of 18FFAPI-74 which is a more practical version of this PET agent due to its longer half-life
Objective
-To compare 18FFAPI-74 PET imaging to 18F-fluorodeoxyglucose 18F-FDG PET imaging and other imaging considered standard of care SOC eg CT andor magnetic resonance imaging MRI to detect sites of cancer in several malignancies
Eligibility
18 years old
Histologically confirmed pancreatic ductal adenocarcinoma PDAC cholangiocarcinoma hepatocellular carcinoma HCC gastric cancer bladder cancer ovarian cancer or pheochromocytoma
Participants must be co-enrolled in an NIH parent cancer treatment clinical trial with the planned evaluation of response per Response Evaluation Criteria in Solid Tumors RECIST v11 and other imaging considered SOC
Eastern Cooperative Oncology Group ECOG Performance score 2
Design
This is a single-site imaging study enrolling participants with PDAC cholangiocarcinoma HCC gastric cancer bladder cancer ovarian cancer or pheochromocytoma With 25 x 7 175 evaluable participants needed we will plan for a small number of inevaluable participants 35 intending to initiate intervention in up to 210 participants Note To allow for screen failures a total of 220 will be set for the purposes of the NIH accrual ceiling
All participants will undergo baseline 18FFAPI-74 PET and 18F-FDG PET imaging
Participants with a positive baseline 18FFAPI-74 PET scan ie with the presence of FAPIpositive tumors will undergo the second 18FFAPI-74 PET imaging at the time of the next re-staging performed on the parent treatment protocol Participants with a negative baseline 18FFAPI-74 PET scan will not have post-treatment 18FFAPI-74 PET or 18F-FDG PET scans performed on this protocol but will remain in follow-up
Participants with a negative baseline 18F-FDG PET scan will not be re-scanned with 18F-FDG PET but may be re-scanned with 18FFAPI-74 PET if baseline 18FFAPI-74 PET imaging is positive
All participants will be followed for 2 years following the first 18FFAPI-74 PET scan to assess progression-free survival and 2-year overall survival During this period participants may undergo the additional 18FFAPI-74 and 18F-FDG PET imaging in case of suspicion for recurrencedisease progression These scans may be done even if the baseline 18FFAPI-74 andor 18F-FDG PET imaging are negative
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