Overview
Sponsor-declared trial summary
Colon cancer
To assess the accuracy of 18F-FAPI-74 PET/CT in detection of local lymph node metastasis in patients with primary colon cancer
Key facts
- Sponsor
- Turku University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Oct 2024 → ongoing
- Decision date (initial)
- 2024-08-20
- 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
To assess the accuracy of 18F-FAPI-74 PET/CT in detection of local lymph node metastasis in patients with primary colon cancer
Conditions and MedDRA coding
Colon cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients with primary colon cancer with suspicion of mesenteric lymph node metastases in computed tomography before primary cancer operation
- Patients with primary colon cancer with potentially curable metastases
- Patients with suspected metastasis or local recurrence in computed tomography and/or elevated carcinoembryonic antigen (CEA) in cancer surveillance
- WHO performance score 0-2
- Patient signs informed consent form after receiving written information
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
- 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
- FAPI-74-PET/CT has a 70 % sensitivity in detecting metastathic lymph nodes
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
- 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
- Saila
Public contact point
- Organisation
- Turku University Hospital
- Contact name
- Saila
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2024-10-14 | 2024-10-14 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-21 | Finland | Acceptable 2024-08-19
|
2024-08-20 |