NCT06659705

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
52mo left

Started Dec 2025

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Dec 2025Aug 2030

First Submitted

Initial submission to the registry

October 21, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 2, 2025

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2030

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

October 21, 2024

Last Update Submit

April 10, 2026

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

Fibroblast Activation Protein InhibitorPositron Emission TomographyPancreatic ductal adenocarcinomaPDACFAPI

Outcome Measures

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.

    12 months

Secondary Outcomes (2)

  • Adverse Event during 68Ga-FAPI-46 PET/CT exams

    12 months

  • Evaluation of the tumor burden 68Ga-FAPI-46 PET/CT versus 18F-FDG PET/CT

    12 months

Study Arms (1)

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).

Drug: 68Ga-FAPI-46 for PET / CT scan

Interventions

68Ga-FAPI-46 for PET / CT scanDRUG

Gallium 68-labeled fibroblast activation protein inhibitor (FAPI) used as radiotracer during PET imaging.

Prospective cohort involving repeated medical imaging with a new radiotracer (68Ga-FAPI-46)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Affiliation to a social security scheme
  • Signed informed consent

You may not qualify if:

  • Protected adults (guardianship, curatorship or safeguarding justice)
  • Pregnant or breastfeeding woman
  • Women of childbearing potential not using one highly effective method of contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Curie -site Saint-Cloud

Saint-Cloud, 92210, France

RECRUITING

MeSH Terms

Interventions

FAPI-462-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Study Officials

  • Nicolas Deleval

    Institut Curie

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Emmanuelle LEGRIER

CONTACT

0033156245765drci.promotion@curie.fr

Sandra NESPOULOUS

CONTACT

0033147111654drci.promotion@curie.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2024

First Posted

October 26, 2024

Study Start

December 2, 2025

Primary Completion (Estimated)

August 4, 2029

Study Completion (Estimated)

August 8, 2030

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
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).

Locations

FR(1)