Fapido

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

14 Feb 2025 → ongoing

Decision date (initial)

2024-12-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

SOFIE · Kom Op Tegen Kanker

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Diagnosis

The aim of the project is to demonstrate superior detection ratio of [18F]AlF-FAPI-74 PET/CT compared to [18F]FDG PET/CT or conventional imaging in treatment-naïve, newly diagnosed patients with oesophagogastric adenocarcinoma (clinical T1-4N0-3M0) and pancreatic ductal adenocarcinoma (clinical T1-4N0-2M0-1) and describe the clinical utility of [18F]AlF-FAPI-74 PET/CT in oncological patients with a clinically challenging situation. It is a prospective, non-randomized, multicenter, multi-cohort, interventional phase II/III trial.

Secondary objectives 1

1. See Trial Synopsis

Conditions and MedDRA coding

Diverse oncological patients with a clinically challenging situation.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
2. Age 18 or older.
3. For OGA: New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma. + Patient underwent a [18F]FDG PET/CT or is planned to have one in the following 4 weeks. + TNM classification: cT1-4N0-3M0
4. For PDAC: New histologic or cytologic proven diagnosis of pancreatic ductal adenocarcinoma. + Patient underwent a [18F]FDG PET/CT or is planned to have one in the following 4 weeks or patient underwent/is planned to have conventional staging with (upper) abdomen CT or (upper) abdomen MRI in the following 4 weeks. + TNM classification: cT1-4N0-2M0-1, with the exception of upfront resectable patients.
5. For the oncology patients with a clinically challenging situation: Histologic or cytologic proven diagnosis of a malignancy. + Patient underwent a [18F]FDG PET/CT of is planned to have one in the following 4 weeks. + Unexplained symptoms, complaints, biochemical or imaging (scintigraphy, PET, CT, MR) findings.

Exclusion criteria 7

1. Participant is mentally or legally incapacitated, doesn’t understand the study design or is not willing or capable to undergo all study-specific procedures.
2. Any disorder or condition, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol.
3. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial.
4. Female who is pregnant (urinary hCG test can be performed in case of doubt), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted).
5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.
6. Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.
7. For PDAC: Patient is upfront resectable.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. OGA: detection ratio for lymph node and distant metastases (combined).
2. PDAC: detection ratio for lymph node and distant metastases (combined).
3. Clinically Challenging Situation: fraction of patients were scan was deemed contributory. This means: 1. [18F]AlF-FAPI-74 identifies a lesion as malignant (true positive) with effective upstaging. 2. [18F]AlF-FAPI-74 identifies a lesion as non-malignant (true negative) with effective downstaging. 3. [18F]AlF-FAPI-74 can differentiate between a malignant or non-malignant lesion when there is doubt. 4. Other implications that are deemed contributory by the treating physician.

Secondary endpoints 1

1. See trial synopsis

Investigational products

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

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Christophe Deroose

Public contact point

Organisation

UZ Leuven

Contact name

Christophe Deroose

Locations

1 EU/EEA country · 3 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 10 files

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

Application history

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