Cutting Edge Imaging With PET-FAPI for Earlier Pancreatic Cancer Diagnosis (INDIGO-FAPI)

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

Development of imaging biomarkers derived from FAPI PET among patients with a newly-diagnosed resectable or locally advanced PDAC, in order (i) to detect a metastatic disease at inclusion and (ii) to detect disease recurrence after surgical resection with a higher sensitivity than the standard evaluation. Prospective cohort involving repeated medical imaging with a new radiotracer (FAPI). Patients meeting inclusion criteria will be stratified according to the disease staging: resectable, borderline or locally advanced PDAC. At inclusion after confirmed non-metastatic PDAC diagnosis, all patients will have: Baseline exams (V1) with 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT (within 1 month after inclusion in HoMING study) for all enrolled patients with resectable, borderline or locally advanced PDAC at inclusion. Second pre-operative exams (V1b) with 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT exams only for patients who received neoadjuvant/induction treatment. Post-operative/Follow-up exams (V2 to Vn) with 68Ga-FAPI-46 PET/CT starting 2 months after surgery (with or without neoadjuvant/induction treatment) or following the neoadjuvant/induction treatment even if the patient is eventually not eligible for surgery (+/-1 month), and then every 3 months (+/-1 month). All patients of this study must have been previously enrolled in the HoMING cohort (NCT 04363983, sponsor APHP). Endpoints and clinical characteristics, as well as results of other biological or imaging exams (MRI, spectral and conventional CT), will be shared with the HoMING cohort. The follow-up ends as soon as conventional CT images show a disease progression/recurrence. Investigators and patients will be blinded for the results of FAPI. Patients will be followed-up according to the care schedule with no modification of patient management. When disease progression/recurrence is diagnosed by conventional CT scan (gold standard), FAPI PET imaging at earlier time points (t -3 months, -6 months…) will be post-hoc reviewed to see whether small lesions could have been detected.

Intervention public domain (ClinicalTrials.gov)

Drug: 68Ga-FAPI-46 for PET / CT scan. Gallium 68-labeled fibroblast activation protein inhibitor (FAPI) used as radiotracer during PET imaging.

Arm public domain (ClinicalTrials.gov)

Prospective cohort involving repeated medical imaging with a new radiotracer (68Ga-FAPI-46) (experimental): All patients of this study must have been previously enrolled in the HoMING cohort (NCT 04363983, sponsor APHP).

Primary outcome public domain (ClinicalTrials.gov)

EFS: Event Free Survival. 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. Time frame: 12 months.

Secondary outcome public domain (ClinicalTrials.gov)

Adverse Event during 68Ga-FAPI-46 PET/CT exams. Time frame: 12 months.

Secondary outcome public domain (ClinicalTrials.gov)

Evaluation of the tumor burden 68Ga-FAPI-46 PET/CT versus 18F-FDG PET/CT. Time frame: 12 months.

Eligibility public domain (ClinicalTrials.gov)

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

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 35 participants (estimated).