Clinical trial • Phase IV • Oncology
Gadoteric acid for Breast cancer
Phase IV trial of Gadoteric acid for Breast cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Breast cancer
- Trial Stage
- Phase IV
- Drug Modality
- Diagnostic agent
Key dates
- Initial CTIS Submission Date
- 21-10-2024
- First CTIS Authorization Date
- 20-02-2025
Trial design
Standard-of-care-dose breast MRI (Dotarem 0.10 mmol/kg) vs AI-enhanced low-dose gadolinium (Dotarem 0.01 mmol/kg additional; total 0.11 mmol/kg)-controlled Phase IV trial across 1 site in Netherlands.
- Comparator
- Standard-of-care-dose breast MRI (Dotarem 0.10 mmol/kg) vs AI-enhanced low-dose gadolinium (Dotarem 0.01 mmol/kg additional; total 0.11 mmol/kg)
- Target Sample Size
- 100
Eligibility
Recruits 100 Vulnerable populations not selected; participants must be able to give informed consent; women who cannot give informed consent are excluded..
- Pregnancy Exclusion
- Pregnant or breastfeeding women
- Vulnerable Population
- Vulnerable populations not selected; participants must be able to give informed consent; women who cannot give informed consent are excluded.
Inclusion criteria
- {"criterion_text":"-Adult women ( > 18 years old) that are scheduled to undergo contrast-enhanced breast MRI"}
Exclusion criteria
- {"criterion_text":"-Women under 18 years old\n-Individuals not scheduled for contrast-enhanced breast MRI\n-Pregnant or breastfeeding women\n-Individuals with contraindications to MRI (e.g., pacemakers, metal implants) and claustrophobia\n-Patients with renal insufficiency (eGFR < 30 ml/min/1.73m2)\n-Patients on hemodialysis or peritoneal dialysis\n-Patients with known allergic reactions to GBCAs\n-Male subjects\n-Women who cannot give informed consent"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Qualitative Evaluation of image quality","definition_or_measurement_approach":""}
- {"endpoint_text":"-Quantitative Evaluation of image quality","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"-Diagnostic performance","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 19
- Consent Approach
- Participants must provide informed consent; women who cannot give informed consent are excluded. Subject information and informed consent form document is available (L1); a Dutch translation exists.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 100
Netherlands
- Earliest CTIS Part Ii Submission Date
- 03-02-2025
- Latest Decision Or Authorization Date
- 20-02-2025
- Processing Time Days
- 17
- Number Of Sites
- 1
- Number Of Participants
- 100
Sites
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Radiology and Nuclear Medicine
- Contact Person Name
- Ritse Maan
- Contact Person Email
- ritse.mann@radboudumc.nl
- Number Of Participants
- 100
Sponsor
Primary sponsor
- Full Name
- Radboud universitair medisch centrum Stichting
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Third parties
- {"country":"","full_name":"European Research Council (ERC)-SAFE-MRI Project","duties_or_roles":"Source of monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- DOTAREM 0,5 mmol/ml oplossing voor injectie in injectieflacons.
- Active Substance
- Gadoteric acid
- Modality
- Diagnostic agent
- Routes Of Administration
- Intravenous administration
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation in NL, RVG 14203)
- Starting Dose
- 0.01 mmol/kg (additional low dose) leading to total 0.11 mmol/kg; comparator standard-of-care 0.10 mmol/kg
- Dose Levels
- 0.01 mmol/kg (low additional) and standard-of-care 0.10 mmol/kg (comparator); total 0.11 mmol/kg
- Frequency
- Single administration
Related trials
Other published trials that may interest you.