Overview
Sponsor-declared trial summary
Gastric cancer
1) To assess the accuracy of 18F-FAPI-74 PET/CT in detection of local lymph node or distant metastasis on patient level in patients with primary GC 2) To assess the accuracy of 18F-FAPI-74 PET/CT in assessing the neoadjuvant therapy response among primary GC patients undergoing surgery
Key facts
- Sponsor
- Varsinais-Suomen hyvinvointialue
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-06-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Diagnosis
1) To assess the accuracy of 18F-FAPI-74 PET/CT in detection of local lymph node or distant metastasis on patient level in patients with primary GC
2) To assess the accuracy of 18F-FAPI-74 PET/CT in assessing the neoadjuvant therapy response among primary GC patients undergoing surgery
Secondary objectives 2
- 1) To calculate inter-rater agreement between the two readers in the FAPI imaging modality
- 2) To assess the accuracy of 18F-FAPI-74 PET/CT in local lymph node metastasis and distant metastasis in patient level in patients with recurrent gastric cancer
Conditions and MedDRA coding
Gastric cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Suspected primary or recurrent gastric cancer
- Subjects must be male or female aged 18-85 years
- WHO performance score 0-2
- Subjects must be able and willing to give written informed consent and to comply with the requirements of the study protocol
Exclusion criteria 3
- Vulnerable study subjects such as described in Finnish law clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included
- Study subject cannot understand the purpose of the purpose of the study
- Medical conditions prohibiting whole-body PET/CT imaging
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary variable of this study is to demonstrate the detection rates of the primary tumor, metastatic lymph nodes and distant metastases in gastric cancer with 18F-FAPI-74 PET/CT
Secondary endpoints 1
- Secondary variable is to demonstrate the detection of distant metastases with 18F-FAPI-74 PET/CT. PET findings are compared to the gold standard of histopathological findings, or in recurrent disease to histopathological findings or routine clinical follow-up CT in one year.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10896779 · Product
- Active substance
- [AL18FFFAPI-74
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 300 MBq megabecquerel(s)
- Max total dose
- 600 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- VARSINAIS-SUOMEN HYVINVOINTIALUE
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Varsinais-Suomen hyvinvointialue
- Sponsor organisation
- Varsinais-Suomen hyvinvointialue
- Address
- Kiinamyllynkatu 4-8
- City
- Turku
- Postcode
- 20520
- Country
- Finland
Scientific contact point
- Organisation
- Varsinais-Suomen hyvinvointialue
- Contact name
- Kajsa Björkman
Public contact point
- Organisation
- Varsinais-Suomen hyvinvointialue
- Contact name
- Kajsa Björkman
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 80 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Clinical Study Protocol Gastro FAPI | 2.0 |
| Recruitment arrangements (for publication) | Recruitment and informed consent procedure 240516 | 2.0 |
| Recruitment arrangements (for publication) | Recruitment Arrangements 240516 | 2.0 |
| Subject information and informed consent form (for publication) | Suostumuslomake_251028 | 2.0 |
| Subject information and informed consent form (for publication) | Tiedote_251029 | 2.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-04-10 | Finland | Acceptable 2026-06-04
|
2026-06-05 |