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

Conditions: Healthy Volunteers; Breast Cancer

Summary: primary purpose of the clinical study is to evaluate the safety, biodistribution and radiation dosimetry of \[131i\]-sgmib anti-her2 vhh1 in healthy volunteers and patients with her2+ breast cancer. secondary purpose of the clinical study is to evaluate the tumor uptake of \[131i\]-sgmib anti-her2 vhh1 in patients with her2+ breast cancer.


Eligibility criteria:
inclusion criteria: subjects will only be included in the study if they meet all of the following criteria: * subjects who have given informed consent * subjects that agree not to drink alcoholic beverages or use any drugs during the study * subject with blood parameters within normal ranges * age: at least 18 years old patients will only be included in the study if they meet all of the following criteria: * patients who have given informed consent * patients that agree not to drink alcoholic beverages or use any drugs during the study * age: at least 18 years old * patients with local, locally advanced or metastatic her2+ breast carcinoma as diagnosed on biopsied tissue by immunohistochemistry or fluorescence in situ hybridization (fish). 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