Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-01-06 @ 8:44 PM
Study NCT ID:
NCT06659705
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cutting Edge Imaging With PET-FAPI for Earlier Pancreatic Cancer Diagnosis (INDIGO-FAPI)
Sponsor:
Institut Curie
Organization:
Study Overview
Official Title:
Cutting Edge Imaging for Earlier Pancreatic Cancer Diagnosis: Evaluation of Positron Emission Tomography (PET) With the Fibroblast Activation Protein Inhibitor (FAPI)
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INDIGO-FAPI
Brief 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.
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:
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 V5) 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.
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 V5) 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: