Prospective cohort involving repeated medical PET-CT imaging with a new radiotracer (FAPI)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut Curie

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

2 Dec 2025 → ongoing

Decision date (initial)

2024-10-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Fondation ARC

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To design imaging biomarkers from 68Ga-FAPI PET/CT images at baseline and assess their association with patient’s prognosis.

Secondary objectives 5

1. To describe the longitudinal evolution of FAPI PET/CT images
2. Among surgically resected patients only, to design imaging biomarkers from 68Ga-FAPI PET/CT images and assess their performances to detect disease recurrence
3. To describe the safety profile of FAPI PET/CT.
4. To compare the rate of detection of regional and distant metastases between 68Ga-FAPI-46 PET/CT and other imaging modalities of routine practice (CT, MRI, 18F-FDG PET/CT)
5. Exploratory: To compare the therapeutic response of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT (functional reference imaging) in the subgroup of patients treated with neoadjuvant chemotherapy.

Conditions and MedDRA coding

Non-metastatic Pancreatic ductal adenocarcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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. 6. Signed informed consent

Exclusion criteria 3

1. Protected adults (guardianship, curatorship or safeguarding justice)
2. Pregnant or breastfeeding woman.
3. 3. Women of childbearing potential not using one highly effective method of contraception during the screening period, during the course of the study and at least 4 months after the last administration of study treatment (see added appendix 4)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time from diagnosis to disease progression, recurrence, or death (EFS: Event Free Survival). Progression or recurrence will be assessed by CT scans performed as part of routine care. The usual time interval between two CT scans is three months, but additional evaluations are possible at the physician’s discretion, e.g. triggered by clinical events.

Secondary endpoints 5

1. FAPI positive volume, SUV of every target lesion
2. Time from surgery to disease recurrence or death (DFS: Disease Free Survival).
3. AEs and SAEs, considered by the investigator as related to 68Ga-FAPI-46 PET-CT, reported by rate and grade (NCI CTC-AEs v5.0).
4. Comparison of 68Ga-FAPI-46 PET/CT and other imaging modalities (CT, MRI and 18F-FDG PET/CT) performances for:  detection of metastases (using the total number of metastatic lesion)  For 18F-FDG PET/CT only, evaluation of the tumor burden (using the total FAP expression tumor volume/TFTV* and the total metabolic tumor volume/TMTV*, respectively). * TMTB is defined as the sum over all lesions of the metabolic tumor volume (MTV) multiplied by the SUVmean in that volume.
5. Exploratory: Difference of SUVmax, FAP and metabolic volume burden defined above (for 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT respectively) before and after neoadjuvant/induction chemotherapy

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut Curie

Sponsor organisation

Institut Curie

Address

35 Rue Dailly

City

Saint-Cloud

Postcode

92210

Country

France

Scientific contact point

Organisation

Institut Curie

Contact name

Cindy NEUZILLET

Public contact point

Organisation

Institut Curie

Contact name

Cindy NEUZILLET

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications