BEFAST: Total Body PET/CT with Ga-68 FAPI for Better Imaging in Cancer
Official title: [68Ga]Ga-FAPI Total Body PET/CT for Improving Diagnostic Sensitivity and Preoperative Staging in Gastroesophageal Cancer and Pancreatic Cancer
Run by Copenhagen University Hospital, Rigshospitalet · NCT07629609 · Data updated 2026-11-12
This study tests whether Ga-68 FAPI-46 Total Body PET/CT can better detect cancer spread and provide fast, clear images for adults with pancreatic or gastroesophageal cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | January 16, 2024 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT07629609 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with suspected pancreatic cancer preparing for curative surgery or adults with histologically confirmed gastroesophageal cancer deemed operable or suitable for oncologic treatment, all able to consent in Danish.
✕Probably not a fit
Patients with advanced or non-operable disease, or those unable to provide Danish consent, may not benefit from this imaging approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2 interventional trial examines the use of [68Ga]Ga-FAPI-46 Total Body PET/CT in adults with pancreatic or gastroesophageal cancer. Participants are divided into groups based on suspected or confirmed disease and surgical candidacy, with the goal of improving metastatic detection and achieving high-quality images within 30 minutes. The study compares this imaging modality to conventional methods, focusing on diagnostic accuracy and speed. Eligibility requires adult patients with specific pancreatic or gastroesophageal cancer criteria and the ability to consent in Danish. The lead site is Rigshospitalet in Copenhagen, with support from the Danish Cancer Society and Herlev Hospital.
Why it matters
Potential benefit: If successful, patients could receive more accurate staging and faster imaging results, potentially guiding treatment decisions.
How similar studies have gone: Previous research in PET imaging with novel tracers has shown promise for improved lesion detection, but the total-body Ga-68 FAPI approach is still being evaluated for broad clinical impact.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Rigshospitalet
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Marie M K Stolberg, MD
- Email: marie.manon.krebs.krarup@regionh.dk
- Phone: +4535454416
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.