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New treatment option for Pancreatic Ductal Adenocarcinoma (PDAC)
Official title Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)
ClinicalTrials.gov ID: NCT07217717
What this study is testing
What is [18F]FAPI-74 PET/CT?
[18F]FAPI-74 PET/CT is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for pancreatic ductal adenocarcinoma (pdac).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of [¹⁸F]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed pancreatic ductal adenocarcinoma. Following screening, using a standardized administration protocol and dose, participants will undergo [¹⁸F]FAPI-74 PET/CT screening.
- Phase 3: a large, late-stage study
- Time commitment: about 3 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and female adults ≥ 18 years.
- Participants with confirmed PDAC, undergoing staging evaluation for treatment planning.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2:
- Provided signed, written informed consent obtained prior to any study-related procedures.
- Participants are required to have a ceCT scan of chest, abdomen and pelvis as per standard clinical practice and practice guidelines either 21 days...
You likely can't join if
- Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option.
- Known hypersensitivity to [¹⁸F]FAPI-74.
- Administration of another investigational therapeutic or diagnostic product within 30 days prior to [¹⁸F]FAPI-74 administration.
- Prior administration of a radiopharmaceutical within 10 half-lives of that product from the time of [¹⁸F]FAPI-74 administration.
- Previous cancer diagnosis (except basal cell carcinoma of the skin or in situ carcinoma of the cervix/uterus). Participants treated with curative...
- Hepatic function: T. bili \>1.5X ULN or alk phos, ALT, or AST \>5X ULN
See the full eligibility criteria
- Male and female adults ≥ 18 years.
- Participants with confirmed PDAC, undergoing staging evaluation for treatment planning.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2:
- Provided signed, written informed consent obtained prior to any study-related procedures.
- Participants are required to have a ceCT scan of chest, abdomen and pelvis as per standard clinical practice and practice guidelines either 21 days or less prior to entry or planned within 21 days of [¹⁸F]FAPI-74...
- For women who are not postmenopausal (two years of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use medically accepted, highly effective methods of contraception (e.g., hormonal...
- Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option.
- Known hypersensitivity to [¹⁸F]FAPI-74.
- Administration of another investigational therapeutic or diagnostic product within 30 days prior to [¹⁸F]FAPI-74 administration.
- Prior administration of a radiopharmaceutical within 10 half-lives of that product from the time of [¹⁸F]FAPI-74 administration.
- Previous cancer diagnosis (except basal cell carcinoma of the skin or in situ carcinoma of the cervix/uterus). Participants treated with curative intent and disease-free for more than 5 years are permitted.
- Hepatic function: T. bili \>1.5X ULN or alk phos, ALT, or AST \>5X ULN
- Renal function: GFR \< 30 mL/min
- Pregnant or breast feeding (a negative pregnancy test is required in women of childbearing potential)
- Inability to undergo the PET/CT scanning procedure.
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Sarcoidosis
- Treatment, including chemotherapy, radiation or surgery for curative intent of PDAC.
The study team makes the final eligibility decision.
Where it's taking place
- Cerritos, California, United States
- Duarte, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Stanford, California, United States
- Tampa, Florida, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Kettering, Ohio, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cerritos, California, United States; Duarte, California, United States; Irvine, California, United States; Los Angeles, California, United States; Stanford, California, United States; Tampa, Florida, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.