Phase 2 study to evaluate the uptake of 68GaNOTA-anti-HER2 VHH1, a new tracer for positron emissie tomografic imaging (PET/CT scan) of brain metastasis in cancer patients.
- Conditions
- brain metastasis lesions from potential HER2 cancer patientsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002328-24-BE
- Lead Sponsor
- Z Brussel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 30
-Patients who have given informed consent
-Female patients
-Age 18 years or older
-Patients with brain metastasised cancer, with at least 1 brain lesion of at least 8 mm maximal diameter, as measured by CT or MRI.
- Patients with potentially HER2-positive cancer. Either a HER2 staining should have been done in standard of care, or sufficient tissue should be available for HER2-staining for study purpose.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
-Male patients
-Pregnant patients
-Breast feeding patients
-Patients with recent (< 1 week) gastrointestinal disorders with diarrhea as major symptom
-Patients with any serious active infection
-Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the test radiopharmaceutical
-Patients who cannot communicate reliably with the investigator
-Patients who are unlikely to cooperate with the requirements of the study
-Patients who are unwilling and/or unable to give informed consent
-Patients at increased risk of death from a pre-existing concurrent illness
-Patients who participated already in this study, or in a previous trial with VHH1.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the uptake of 68GaNOTA-Anti-HER2 VHH1 in brain metastasis lesions from HER2-positive and HER2-negative patients.;Secondary Objective: Not applicable;Primary end point(s): The tumor targeting potential in brain metastasis ;Timepoint(s) of evaluation of this end point: end of trial
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The tumor targeting potential in other than brain metastasis ;Timepoint(s) of evaluation of this end point: end of trial