Pancreatic Ductal Adenocarcinoma (PDAC)Phase 2INDIGO-FAPINCT06659705
Cutting Edge Imaging With PET-FAPI for Earlier Pancreatic Cancer Diagnosis (INDIGO-FAPI)
A Phase 2 study testing 68Ga-FAPI-46 for PET / CT scan in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Institut Curie at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- 68Ga-FAPI-46 for PET / CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2025to 8 Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Protected adults (guardianship, curatorship or safeguarding justice)
- Pregnant or breastfeeding woman
- Women of childbearing potential not using one highly effective method of contraception
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Curie -site Saint-Cloud
Saint-Cloud, 92210
Nicolas Deleval, MD
Nicolas Deleval, MD
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- 68Ga-FAPI-46 for PET / CT scan
- Keywords
- Fibroblast Activation Protein Inhibitor, Positron Emission Tomography, Pancreatic ductal adenocarcinoma, PDAC, FAPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-46 for PET / CT scanDrug
Gallium 68-labeled fibroblast activation protein inhibitor (FAPI) used as radiotracer during PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: 68Ga-FAPI-46 for PET / CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Adverse Event during 68Ga-FAPI-46 PET/CT exams
Description the safety profile of 68Ga-FAPI-46 PET/CT exams
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start2 Dec 2025
- Primary completion4 Aug 2029 (estimated)
- Study completion8 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Deleval, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659705
- Sponsor's protocol ID
- IC 2023-02
- Acronym
- INDIGO-FAPI
- Status last verified
- Apr 2026
- First submitted
- 21 Oct 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutting Edge Imaging for Earlier Pancreatic Cancer Diagnosis: Evaluation of Positron Emission Tomography (PET) With the Fibroblast Activation Protein Inhibitor (FAPI)
- ClinicalTrials.gov ID
- NCT06659705
- Acronym / sponsor ID
- INDIGO-FAPI / IC 2023-02
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Keywords
- Fibroblast Activation Protein Inhibitor, Positron Emission Tomography, Pancreatic ductal adenocarcinoma, PDAC, FAPI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 4 Aug 2029 (estimated)
- Study completion
- 8 Aug 2030 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort involving repeated medical imaging with a new radiotracer (68Ga-FAPI-46) | Experimental | Drug: 68Ga-FAPI-46 for PET / CT scanAll patients of this study must have been previously enrolled in the HoMING cohort (NCT 04363983, sponsor APHP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Protected adults (guardianship, curatorship or safeguarding justice)
- Pregnant or breastfeeding woman
- Women of childbearing potential not using one highly effective method of contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-FAPI-46 for PET / CT scanGallium 68-labeled fibroblast activation protein inhibitor (FAPI) used as radiotracer during PET imaging. | Drug | Prospective cohort involving repeated medical imaging with a new radiotracer (68Ga-FAPI-46) |
Primary outcome
EFS: Event Free Survival
Time frame: 12 months
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.
2 secondary outcomes
Adverse Event during 68Ga-FAPI-46 PET/CT exams
Time frame: 12 months
Evaluation of the tumor burden 68Ga-FAPI-46 PET/CT versus 18F-FDG PET/CT
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Related trials for Pancreatic Ductal Adenocarcinoma (PDAC)
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RecruitingPhase 2
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RecruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas Deleval principal investigator
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-FAPI-46 for PET / CT scan in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Emmanuelle LEGRIER (0033156245765, drci.promotion@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFS: Event Free Survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.