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68Ga-FAPI-46 PET for imaging of gastrointestinal cancers: A prospective interventional single-arm clinical trial (FAPI-PET-GI)
EU CTIS ID: 2023-506030-70-00
What this study is testing
To evaluate the validity of 68Ga-FAPI-46 PET (positron emission tomography) inter- and intraindividual in patients with gastrointestinal cancers
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Proven or suspected gastrointestinal cancers including: - Hepatocellular carcinoma - Cholangiocarcinoma - Gastric cancer - Pancreatic cancer - Colorectal cancer - Oesophageal cancer
- At initial staging or re-staging of disease
- At least one detectable tumour lesion with any diameter > 1cm
- Intended or performed surgery of biopsy of tumor within 8 weeks before or 8 weeks after enrollment and participants consent to utilise biopsy/tumour specimen for immunohistochemical analysis of FAP expression
- Age ≥ 18 years
- Participant Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
You likely can't join if
- Participant cannot give consent for the study
- Sexually active males must use a condom during intercourse during the interventional period. A condom is required to be used also by vasectomized men in order to prevent delivery of the study compound via seminal fluid
- QTcF >470 msec for females and QTcF >450 msec for males on screening ECG or history of congenital long QT syndrome
- Known or expected hypersensitivity to 68Ga-68-FAPI-46 or any of the relevant excipients
- Participant can not lie flat or tolerate 68Ga-FAPI-46 PET imaging
- Prior external beam radiation therapy (EBRT) within 1 month of enrolment to tumour lesions intended for surgery or biopsy
See the full eligibility criteria
Who can join
- Proven or suspected gastrointestinal cancers including: - Hepatocellular carcinoma - Cholangiocarcinoma - Gastric cancer - Pancreatic cancer - Colorectal cancer - Oesophageal cancer
- At initial staging or re-staging of disease
- At least one detectable tumour lesion with any diameter > 1cm
- Intended or performed surgery of biopsy of tumor within 8 weeks before or 8 weeks after enrollment and participants consent to utilise biopsy/tumour specimen for immunohistochemical analysis of FAP expression
- Age ≥ 18 years
- Participant Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Women of child bearing potential (WOCBP), defines as all women physiologically capable of becoming pregnant, can only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test within 24 hours before radiopharmaceutical application
What rules you out
- Participant cannot give consent for the study
- Sexually active males must use a condom during intercourse during the interventional period. A condom is required to be used also by vasectomized men in order to prevent delivery of the study compound via seminal fluid
- QTcF >470 msec for females and QTcF >450 msec for males on screening ECG or history of congenital long QT syndrome
- Known or expected hypersensitivity to 68Ga-68-FAPI-46 or any of the relevant excipients
- Participant can not lie flat or tolerate 68Ga-FAPI-46 PET imaging
- Prior external beam radiation therapy (EBRT) within 1 month of enrolment to tumour lesions intended for surgery or biopsy
- Prior chemotherapy, immunotherapy, biologic or targeted oncologic therapy within 1 month prior 68Ga-FAPI-46 PET
- Unwillingness or inability to comply with study and follow-up procedures
- History of disease or condition that may critically interfere with participation in this study at the discretion of the investigators
- Pregnant, lactating, or breast-feeding women
- Women of child bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, are not allowed to participate in this study, unless they are using highly effective methods of contraception during the interventional period. Highly effective contraception methods include: • True sexual abstinence: defined as refraining from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to IMP, and withdrawal are not acceptable methods of contraception.• Vasectomised partner is a highly effective birth control method if the partner is the sole sexual partner of the study participant and the vasectomised partner has received medical assessment of the surgical success. • Bilateral tubal occlusion. • Combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: - oral - intravaginal - transdermal• Progestogen-only hormonal contraception associated with inhibition of ovulation: - oral - injectable - implantable • Placement of an intrauterine device or intrauterine hormone-releasing system
- Post-menopausal women are allowed to participate in this study. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms), or six months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40mIU/mL or have had surgical bilateral oophorectomy or bilateral salpingectomy or hysterectomy or tubal ligation at least six weeks prior to screening. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
The study team makes the final eligibility decision.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.