Clinical trial • Phase IV • Oncology
[AL[18F]F]FAPI-74 for Colon cancer
Phase IV trial of [AL[18F]F]FAPI-74 for Colon cancer. 100 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Colon cancer
- Trial Stage
- Phase IV
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 21-05-2024
- First CTIS Authorization Date
- 20-08-2024
Trial design
Phase IV trial across 1 site in Finland.
- Target Sample Size
- 100
Eligibility
Recruits 100 Vulnerable populations are explicitly excluded: "disabled, children, pregnant or breast-feeding women, prisoners" will not be included. Participants must be able to understand the purpose of the study; informed consent is required (patient signs informed consent form after receiving written information). No assent procedure or special consent languages are specified..
- Pregnancy Exclusion
- Vulnerable study subjects such as described in Finnish law clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included
- Vulnerable Population
- Vulnerable populations are explicitly excluded: "disabled, children, pregnant or breast-feeding women, prisoners" will not be included. Participants must be able to understand the purpose of the study; informed consent is required (patient signs informed consent form after receiving written information). No assent procedure or special consent languages are specified.
Inclusion criteria
- {"criterion_text":"- Patients with primary colon cancer with suspicion of mesenteric lymph node metastases in computed tomography before primary cancer operation\n- Patients with primary colon cancer with potentially curable metastases\n- Patients with suspected metastasis or local recurrence in computed tomography and/or elevated carcinoembryonic antigen (CEA) in cancer surveillance\n- WHO performance score 0-2\n- Patient signs informed consent form after receiving written information"}
Exclusion criteria
- {"criterion_text":"- Vulnerable study subjects such as described in Finnish law clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included\n- Patient is not able to understand purpose of study\n- Medical conditions prohibiting whole body PET-CT"}
Endpoints
Primary endpoints
- {"endpoint_text":"- FAPI-74-PET/CT has a 70 % sensitivity in detecting metastathic lymph nodes","definition_or_measurement_approach":"Assess sensitivity of 18F-FAPI-74 PET/CT in detecting metastatic lymph nodes (target sensitivity specified as 70 %)."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 24
- Consent Approach
- Patients must sign an informed consent form after receiving written information. Participants must be able to understand the purpose of the study; no details on assent, age-specific documents, or languages are provided.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 100
Finland
- Earliest CTIS Part Ii Submission Date
- 22-07-2024
- Latest Decision Or Authorization Date
- 20-08-2024
- Processing Time Days
- 29
- Number Of Sites
- 1
- Number Of Participants
- 100
Sites
- Site Name
- Turku University Hospital
- Department Name
- Department of gastrointestinal surgery
- Principal Investigator Name
- Saila Kauhanen
- Principal Investigator Email
- saila.kauhanen@utu.fi
- Contact Person Name
- Saila Kauhanen
- Contact Person Email
- saila.kauhanen@utu.fi
Sponsor
Primary sponsor
- Full Name
- Turku University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- [18F]FAPI-74
- Active Substance
- [AL[18F]F]FAPI-74
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised (prodAuthStatus=1)
- Maximum Dose
- 400 MBq
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