PET-FAPI imaging to find pancreatic cancer earlier
Cutting Edge Imaging for Earlier Pancreatic Cancer Diagnosis: Evaluation of Positron Emission Tomography (PET) With the Fibroblast Activation Protein Inhibitor (FAPI)
This will try a PET scan using a FAPI tracer to find early or returning pancreatic cancer in adults with recently diagnosed non‑metastatic PDAC who are enrolled in the HoMING cohort.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Curie Academic / other |
| Locations | 1 site (Saint-Cloud) |
| Trial ID | NCT06659705 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional protocol uses repeated 68Ga-FAPI-46 PET/CT scans alongside standard 18F-FDG PET/CT and conventional imaging to develop and test imaging biomarkers in patients with newly diagnosed resectable, borderline, or locally advanced non‑metastatic PDAC. All participants must already be enrolled in the HoMING cohort and will receive a baseline FAPI and FDG PET/CT, additional pre-operative scans if they receive neoadjuvant therapy, and post-operative or post-treatment FAPI PET/CT starting about two months after surgery and then every three months. The co-primary goals are to detect occult metastatic disease at inclusion and to detect recurrence after resection with higher sensitivity than standard CT/MRI. Follow-up ends if conventional imaging documents progression or relapse, or at death, and FAPI findings will be compared with clinical, pathological and other imaging results from HoMING.
Who should consider this trial
Good fit: Ideal candidates are adults (>18) with cyto/histologically proven non‑metastatic PDAC (resectable, borderline or locally advanced) who are already enrolled in the HoMING prospective cohort and can undergo PET/CT imaging.
Not a fit: Patients with known metastatic disease at baseline, pregnant or breastfeeding women, legally protected adults without consent capacity, or individuals not enrolled in HoMING are not eligible and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, FAPI PET could detect metastasis or recurrence earlier than standard scans, potentially allowing earlier treatment changes and better selection of patients for surgery.
How similar studies have performed: Early pilot studies and small series in PDAC and other cancers have shown promising tumor uptake and improved lesion detection with FAPI‑PET versus FDG‑PET, but large prospective validation is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Cyto/histologically proven PDAC 2. Non-metastatic proven PDAC on recent (\< 1 month) CT-scan and MRI 3. Concomitant enrollment in the HoMING prospective cohort (Sponsor: AP-HP, NCT04363983) 4. Age \> 18 years old 5. Affiliation to a social security scheme 6. Signed informed consent Exclusion Criteria: 1. Protected adults (guardianship, curatorship or safeguarding justice) 2. Pregnant or breastfeeding woman 3. Women of childbearing potential not using one highly effective method of contraception
Where this trial is running
Saint-Cloud
- Institut Curie -site Saint-Cloud — Saint-Cloud, France (Recruiting)
Study contacts
- Principal investigator: Nicolas Deleval — Institut Curie
- Study coordinator: Marie-Emmanuelle LEGRIER
- Email: drci.promotion@curie.fr
- Phone: 0033156245765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.