Cutting Edge Imaging With PET-FAPI for Earlier Pancreatic Cancer Diagnosis (INDIGO-FAPI)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Curie
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Cyto/histologically proven PDAC
Non-metastatic proven PDAC on recent (< 1 month) CT-scan and MRI
Concomitant enrollment in the HoMING prospective cohort (Sponsor: AP-HP, NCT04363983)
Age > 18 years old
Disqualifiers
Protected adults (guardianship, curatorship or safeguarding justice)
Pregnant or breastfeeding woman
Women of childbearing potential not using one highly effective method of contraception
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-FAPI-46 for PET / CT scan
DrugGallium 68-labeled fibroblast activation protein inhibitor (FAPI) used as radiotracer during PET imaging.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Prospective cohort involving repeated medical imaging with a new radiotracer (68Ga-FAPI-46)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
Adverse Event during 68Ga-FAPI-46 PET/CT exams
Description the safety profile of 68Ga-FAPI-46 PET/CT exams
Time frame
12 months2
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)
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov