Clinical trial • Phase IV • Oncology
[AL[18F]F]FAPI-74 for Pancreatic cancer
Phase IV trial of [AL[18F]F]FAPI-74 for Pancreatic cancer. None/Not specified-controlled. 100 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Pancreatic 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
None/Not specified-controlled Phase IV trial across 1 site in Finland.
- Comparator
- None/Not specified
- Target Sample Size
- 100
Eligibility
Recruits 100 Vulnerable study subjects (disabled, children, pregnant or breast-feeding women, prisoners) will not be included; subjects unable to understand the purpose of the study are excluded. Participants must sign an informed consent form after receiving written information..
- 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 study subjects (disabled, children, pregnant or breast-feeding women, prisoners) will not be included; subjects unable to understand the purpose of the study are excluded. Participants must sign an informed consent form after receiving written information.
Inclusion criteria
- {"criterion_text":"- Primary or recurrent pancreatic cancer"}
- {"criterion_text":"- Suspected primary or recurrent pancreatic cancer"}
- {"criterion_text":"- Male or female aged 18-85 years"}
- {"criterion_text":"- WHO performance score 0-2"}
- {"criterion_text":"- Study subject 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"}
- {"criterion_text":"- Study subject is not able to understand the purpose of the study"}
- {"criterion_text":"- Medical conditions prohibiting whole-body PET/CT imaging"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 18F-FAPI-74 PET/CT has a 70 % sensitivity in detecting metastatic lymph nodes","definition_or_measurement_approach":"70 % sensitivity in detecting metastatic lymph nodes; measured at patient level by 18F-FAPI-74 PET/CT as specified in the main objective to assess accuracy in detection of local lymph node metastasis in patient level."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 24
- Consent Approach
- Study subject signs informed consent form after receiving written information. Subjects unable to understand the purpose of the study are excluded.
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
- spkauha@utu.fi
- Contact Person Name
- Saila Kauhanen
- Contact Person Email
- spkauha@utu.fi
- Number Of Participants
- 100
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 BOLUS INJECTION/IV INFUSION
- Route
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Maximum Dose
- 400 MBq
Related trials
Other published trials that may interest you.