BEFAST Study, [68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer (NCT07629609) | Clinical Trial Compass
RecruitingPhase 2
BEFAST Study, [68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
Denmark90 participantsStarted 2024-01-16
Plain-language summary
The goal of this clinical trial is to learn if \[68Ga\]Ga-FAPI-46 Total Body PET/CT can diagnose patients suffering from gastroesophageal cancer and pancreatic cancer. The investigators hope that \[68Ga\]Ga-FAPI-46 Total Body PET/CT can improve staging and treatment evaluation for these patient groups.
The main questions the trial aims to answer are:
* Is \[68Ga\]Ga-FAPI-46 Total Body PET/CT better at diagnosing metastatic disease in the abdomen compared other imaging modalities?
* Can \[68Ga\]Ga-FAPI-46 Total Body PET/CT produce accurate images in less than 30 min?
Researchers will examine three different patient groups:
Group A) patients with pancreatic cancer, who are referred to surgery. Group B1) patients with gastroesophageal cancer, who are referred to diagnostic surgery (laparoscopy).
Group B2) a subgroup of gastroesophageal cancer patients, with a specific subtype cancer (signet ring cell carcinoma or poorly cohesive carcinoma), who are referred to oncological treatment.
Participants will undergo:
* One \[68Ga\]Ga-FAPI Total Body PET/CT before surgery (Group A), or before laparoscopy (group B1), or before oncological treatment (Group B2).
* Participants in group B2 will also undergo a second \[68Ga\]Ga-FAPI-46 Total Body PET/CT during treatment with chemotherapy.
* All participants will fill out one questionnaire.
* Researchers will follow the patients after the scans for 1 year.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, over 18 years old
. Patients with suspected pancreatic cancer based on morphological findings on standard imaging
. CT or MRI or \[18F\]FDG PET/CT evaluated on MDT with no initial sign of distant metastases
. Subjects must have been considered suitable for curative surgery at the time of the referral
. Subjects must be able to read and understand the patient information in Danish to give informed consent
. Male or female over 18 years old
. Histological verified carcinoma from the lower esophagus, GEJ, or stomach
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of [68Ga]Ga-FAPI-46 Total Body PET/CT
Timeframe: From the time of scan to the end of follow up at 1 year