Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients

Exclusion Criteria

• •Patients will not be included in the study if one of the following criteria applies:
• •Pregnant patients
• •Breast feeding patients
• •Patients with occupational exposure to ionizing irradiation
• •Patients with previous thyroid disorders
• •Patients that received radiolabeled compounds with a long half-life (\>7h) for diagnostic or therapeutic purposes within the last 2 days.
• •Patients with absolute contra-indications for thyroid blockage with potassium iodide.
• •Patients with abnormal liver: ALT/AST \> 2 times normal values; bilirubin \> 1.5 time normal values.
• •Patients with abnormal kidney function: \< 50 ml/min/1,73 m2
• •Patients with recent (\< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) 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 safety 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 at increased risk of death from a pre-existing concurrent illness
• •Patients who participated already in this study
• •Patients who participated in a previous trial with Anti-HER2 VHH1
• •Subjects will not be included in the study if one of the following criteria applies:
• •Pregnant subjects
• •Breast feeding subjects
• •Subjects with occupational exposure to ionizing irradiation
• •Subjects with clinical significant disease or on concomitant therapy (except contraception)
• •Subjects with previous thyroid disorders
• •Subjects that received radiolabeled compounds with a long half-life (\>7h) for diagnostic or therapeutic purposes within the last 2 days.
• •Subjects with absolute contra-indications for thyroid blockage with potassium iodide.
• •Subjects with abnormal liver: ALT/AST \> 2 times normal values; bilirubin \> 1.5 time normal values.
• •Subjects with abnormal kidney function: \< 50 ml/min/1,73 m2
• •Subjects with recent (\< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
• •Subjects with any serious active infection
• •Subjects who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test radiopharmaceutical
• •Subjects who cannot communicate reliably with the investigator
• •Subjects who are unlikely to cooperate with the requirements of the study
• •Subjects at increased risk of death from a pre-existing concurrent illness
• •Subjects who participated already in this study
• •Subjects who participated in a previous trial with Anti-HER2 VHH1