Clinical trial · Interventional
Cutting Edge Imaging With PET-FAPI for Earlier Pancreatic Cancer Diagnosis (INDIGO-FAPI)
Cutting Edge Imaging for Earlier Pancreatic Cancer Diagnosis: Evaluation of Positron Emission Tomography (PET) With the Fibroblast Activation Protein Inhibitor (FAPI)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAPI-46 for PET / CT scan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prospective cohort involving repeated medical imaging with a new radiotracer (68Ga-FAPI-46)
- description
- All patients of this study must have been previously enrolled in the HoMING cohort (NCT 04363983, sponsor APHP).
- interventionNames
- Drug: 68Ga-FAPI-46 for PET / CT scan
Primary outcomes (1)
- measure
- EFS: Event Free Survival
- timeFrame
- 12 months
- description
- 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.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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