68Ga-FAPI-46 for PET / CT scan: Gallium 68-labeled fibroblast activation protein inhibitor (FAPI) used as radiotracer during PET imaging.
Study summary
Assessment of the relevance of a new medical imaging test, FAPI PET, which could detect progression or relapse earlier than other tests currently available. Ultimately, it could enable early forms of pancreatic cancer to be detected and used for screening.
In addition to the usual examinations prescribed, FAPI PET scans will be repeated at several points in the treatment process.
All study patients must first have been included in the Homing cohort (NCT 04363983, APHP promotion). Clinical characteristics, judgement criteria and results of biological or imaging examinations carried out as part of this cohort will be shared.
Patient follow-up and participation in the study ends when conventional imaging (CT and MRI) shows disease progression, relapse or death.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
EFS: Event Free Survival — 12 months Time from diagnosis to disease progression, recurrence or death (EFS: Event Free Survival). Radiomic features from the initial FAPI evaluation will be analyzed using univariable and multivariable survival models to detect and quantify statistical associations between feature values and EFS. A multivariable model will be proposed and will serve as basis for the estimation of screening sensitivity.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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