NCT07629609 BEFAST Study, [68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
| NCT ID | NCT07629609 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Barbara Malene Fischer |
| Condition | Pancreatic Cancer, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-01-16 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2024-01-16 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion criteria for group A 1. Male or female, over 18 years old 2. Patients with suspected pancreatic cancer based on morphological findings on standard imaging 3. CT or MRI or \[18F\]FDG PET/CT evaluated on MDT with no initial sign of distant metastases 4. Subjects must have been considered suitable for curative surgery at the time of the referral 5. Subjects must be able to read and understand the patient information in Danish to give informed consent Inclusion criteria for group B1 1. Male or female over 18 years old 2. Histological verified carcinoma from the lower esophagus, GEJ, or stomach 3. Subjects must be considered operable and resectable at the time of referral for MDT 4. Subjects must be able to read and understand the patient information in Danish to give informed consent Inclusion criteria for group B2 1. Male or female over 18 years old 2. Histological verified SRCC or PCC from the lower esophagus, GEJ, or stomach 3. Subjects with localized disease assigned to perioperative chemotherapy or subjects with metastatic disease assigned to palliative systemic treatment. 4. Subjects must be able to read and understand the patient information in Danish to give informed consent Exclusion Criteria: 1. Pregnancy or lactation 2. Weight more than the maximum limit of a PET/CT-scanner bed (140 kg) 3. History of allergic reaction due to compounds similar to the chemical composition of \[68Ga\]Ga-FAPI-46
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07629609 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07629609 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07629609 currently recruiting?
Yes, NCT07629609 is actively recruiting participants. Contact the research team at marie.manon.krebs.krarup@regionh.dk for enrollment information.
Where is the NCT07629609 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT07629609 clinical trial?
NCT07629609 is sponsored by Barbara Malene Fischer. The trial plans to enroll 90 participants.
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