Overview
Sponsor-declared trial summary
Non small cell lung cancer
1) To explore the feasibility of 18F-FAPI-74 PET/CT imaging in the clinical assessment of patients with lymph node metastases in NSCLC 2) To explore the feasibility of 18F-FAPI-74 PET/CT imaging in the assessment of cancer related distant metastasis in patient level in patients with primary NSCLC 3) To explore the feas…
Key facts
- Sponsor
- Turku University Hospital
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-12-16
- 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: Diagnosis
1) To explore the feasibility of 18F-FAPI-74 PET/CT imaging in the clinical assessment of patients with lymph node metastases in NSCLC
2) To explore the feasibility of 18F-FAPI-74 PET/CT imaging in the assessment of cancer related distant metastasis in patient level in patients with primary NSCLC
3) To explore the feasibility of 18F-FAPI-74 PET/CT imaging in the assessesment of cancer related local lymph metastasis and distant metastasis in patient level in patients with recurrent NSCL.
Conditions and MedDRA coding
Non small cell lung cancer
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-519091-77-02 | The Expression of Fibroblast Activation Protein in Patients with Non-Small Cell Lung Cancer Patients | Turku University Hospital |
| 2024-519091-77-01 | The Expression of Fibroblast Activation Protein in Patients with Non-Small Cell Lung Cancer Patients | Turku University Hospital |
| 2024-519091-77-00 | The Expression of Fibroblast Activation Protein in Patients with Non-Small Cell Lung Cancer Patients | Turku University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Diagnosis: Histologically confirmed adenocarcinoma or squamous cell carcinoma. Study 1: No previous treatment (surgical, radiotherapy or medical treatment) for NSCLC. Study 2: Lobectomy or stereotactical radiotherapy or chemoradiotherapy for NSCLC. Clinical stage: Study 1: Stage I-III, Age: > 18 yo.
Exclusion criteria 1
- - Infections: Patient must not have an uncontrolled serious infection - no other malignancies - no known history of sarcoidosis - Study 2: under six months after radiotherapy - Patient is not able to understand purpose of study - Medical conditions prohibiting whole body PET-CT
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- SUVmax, SUVmean and SUVpeak of the primary tumor, tumor recurrence, lymph node metastasis or distant metastasis
Secondary endpoints 1
- Histological confirmation of cancer in lesions with FAPI PET -imaging
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
- INTRAVENOUS INJECTION
- Max daily dose
- 400 MBq megabecquerel(s)
- Max total dose
- 400 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
Turku University Hospital
- Sponsor organisation
- Turku University Hospital
- Address
- Kiinamyllynkatu 4-8
- City
- Turku
- Postcode
- 20520
- Country
- Finland
Scientific contact point
- Organisation
- Turku University Hospital
- Contact name
- Jukka Kemppainen
Public contact point
- Organisation
- Turku University Hospital
- Contact name
- Jukka Kemppainen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 60 | 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 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | NSCLC study protocol LungCa FAPI v2 | 2 |
| Protocol (for publication) | NSCLC study protocol LungCa FAPI v2_korjaukset | 2 |
| Recruitment arrangements (for publication) | Recruitment and Informed consent procedure_new trail no | 1 |
| Subject information and informed consent form (for publication) | Suostumuslomake v2 | 2 |
| Subject information and informed consent form (for publication) | Suostumuslomake v2_korjaukset | 2 |
| Subject information and informed consent form (for publication) | Tiedote tutkimuksesta LUNG_FAPI v2 | 2 |
| Subject information and informed consent form (for publication) | Tiedote tutkimuksesta LUNG_FAPI v2_korjaukset2 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-23 | Finland | Acceptable 2025-12-08
|
2025-12-16 |