This study is NOT currently recruiting participants.
Number
001731-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Recruitment has not started Gender: Male & Female Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
Children;Neonates;Fetuses;Pregnant Women
Keywords
Fluorodeoxyglucose F18; PET Imaging; 18F-Fibroblast Activation Protein Inhibitor
Recruitment Keyword(s)
None
Condition(s)
Pancreatic ductal adenocarcinoma; Cholangiocarcinoma; Gastric Cancer; Bladder Cancer; Hepatocellular Carcinoma; Pheochromocytoma; Ovarian Cancer
Investigational Drug(s)
[18F]FAPI-74
Investigational Device(s)
Intervention(s)
Drug: [18F]FAPI-74 Drug: [18F]FDG
Supporting Site
National Cancer Institute
Fibroblast-activation protein (FAP) is an enzyme that appears in high numbers in certain cancer cells. [18F]FAPI-74 is a new tracer-a substance that is injected into a person s body before an imaging scan. Researchers believe that [18F]FAPI-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 [18F]FAPI-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 [18F]FAPI-74; 1 with an approved tracer.
The [18F]FAPI-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 [18F]FAPI-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 [18F]FAPI-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.
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INCLUSION CRITERIA: - 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 planned evaluation of response per RECIST v.1.1 and other imaging considered standard of care (SOC). - Evaluable disease - >= 18 years old. - Eastern Cooperative Oncology Group (ECOG) performance score <= 2. -Women of child-bearing potential (WOCBP) and men must agree to use effective contraception (barrier, hormonal, intrauterine device [IUD], surgical sterilization, abstinence) at the study entry and for 2 months after each [18F]FAPI-74 imaging. Men must not freeze or donate sperm within the same period. - Breastfeeding participants must be willing to discontinue breastfeeding for 2 months after each study imaging. - The ability of participant to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: -History of allergic reactions attributed to compounds of similar chemical or biologic composition to [18F]FAPI-74 or other agents used in the study. -History of severe claustrophobia unresponsive to oral anxiolytics or history of any other condition preventing the ability to lie on the imaging scanner for up to 45 minutes. -Weight > 350 lbs., or inability to fit within the imaging gantry. -Positive Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening. -Uncontrolled intercurrent illness, or medical condition(s) including but not limited to renal failure, liver failure, or psychiatric illness/social situations evaluated by medical history and physical exam that would limit compliance with study requirements and potentially increase risk for the participant. -Serum creatinine > 2 times the upper limit of normal. -Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal.
- 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 planned evaluation of response per RECIST v.1.1 and other imaging considered standard of care (SOC).
- Evaluable disease
- >= 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance score <= 2.
-Women of child-bearing potential (WOCBP) and men must agree to use effective contraception (barrier, hormonal, intrauterine device [IUD], surgical sterilization, abstinence) at the study entry and for 2 months after each [18F]FAPI-74 imaging. Men must not freeze or donate sperm within the same period.
- Breastfeeding participants must be willing to discontinue breastfeeding for 2 months after each study imaging.
- The ability of participant to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
-History of allergic reactions attributed to compounds of similar chemical or biologic composition to [18F]FAPI-74 or other agents used in the study.
-History of severe claustrophobia unresponsive to oral anxiolytics or history of any other condition preventing the ability to lie on the imaging scanner for up to 45 minutes.
-Weight > 350 lbs., or inability to fit within the imaging gantry.
-Positive Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening.
-Uncontrolled intercurrent illness, or medical condition(s) including but not limited to renal failure, liver failure, or psychiatric illness/social situations evaluated by medical history and physical exam that would limit compliance with study requirements and potentially increase risk for the participant.
-Serum creatinine > 2 times the upper limit of normal.
-Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal.
Principal Investigator
Referral Contact
For more information: