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

Cutting Edge Imaging for Earlier Pancreatic Cancer Diagnosis: Evaluation of Positron Emission Tomography (PET) With the Fibroblast Activation Protein Inhibitor (FAPI)

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
• Intervention / Treatment: Drug: 68Ga-FAPI-46 for PET / CT scan

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Marie-Emmanuelle LEGRIER; Phone Number: 0033156245765; Email: drci.promotion@curie.fr
• Study Contact Backup: Name: Sandra NESPOULOUS; Phone Number: 0033147111654; Email: drci.promotion@curie.fr

Study Locations

• France
  • Saint-Cloud, France, 92210
    • Recruiting
    • Institut Curie -site Saint-Cloud
    • Contact: Nicolas Deleval, MD
    • Principal Investigator: Nicolas Deleval, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective cohort involving repeated medical imaging with a new radiotracer (68Ga-FAPI-46); All patients of this study must have been previously enrolled in the HoMING cohort (NCT 04363983, sponsor APHP).	Drug: 68Ga-FAPI-46 for PET / CT scan; Gallium 68-labeled fibroblast activation protein inhibitor (FAPI) used as radiotracer during PET imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event during 68Ga-FAPI-46 PET/CT exams	Description the safety profile of 68Ga-FAPI-46 PET/CT exams	12 months
Evaluation of the tumor burden 68Ga-FAPI-46 PET/CT versus 18F-FDG PET/CT	Comparison of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT (Comparison of the tumor burden using the total FAP expression tumor volume/TFTV and the total metabolic tumor volume/TMTV*, respectively)	12 months

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: Nicolas Deleval, Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2025
• Primary Completion (Estimated): August 4, 2029
• Study Completion (Estimated): August 8, 2030

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Positron Emission Tomography; Pancreatic ductal adenocarcinoma; PDAC; FAPI; Fibroblast Activation Protein Inhibitor
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; FAPI-46; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole
• Other Study ID Numbers: IC 2023-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No