18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection

Description

Background: 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.

Conditions

Pancreatic Ductal Adenocarcinoma, Cholangiocarcinoma, Gastric Cancer, Bladder Cancer, Hepatocellular Carcinoma, Pheochromocytoma, Ovarian Cancer

Study Overview

Study Details

Study overview

Background: 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.

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection

Condition
Pancreatic Ductal Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Bethesda

National Institutes of Health Clinical Center, Bethesda, Maryland, United States, 20892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Histologically confirmed pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma, small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancer (EP-NEC), mesothelioma or sarcoma.
  • * 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.
  • * Individuals of child-bearing potential (IOCBP) and individuals that can father children 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. Sperm may not be frozen or donated within the same period.
  • * 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.
  • * 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 IOCBP 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.

Ages Eligible for Study

18 Years to 120 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

National Cancer Institute (NCI),

Esther Mena Gonzalez, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

2030-06-01