Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Universitair Ziekenhuis Brussel
With
Kom Op Tegen Kanker
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
PART I:
Patients will only be included in the study if they meet all of the following criteria:
Patients who have given informed consent
Patients at least 18 years old
Patients with local, locally advanced or metastatic disease of a malignant solid tumor. In order to minimize partial volume effect the diameter of at least 1 tumor lesion should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions.
Patients will only be included in the study if they meet all of the following criteria:
Patients who have given informed consent
Patients at least 18 years old
Patients diagnosed with a local, locally advanced or metastatic disease, with any of the following cancer types :
Triple-negative breast carcinoma,
Hormone-receptor negative (HR-), HER2+ breast carcinoma, with HER2-expression defined as HER2+ on ISH or 3+ on IHC, as determined by local assessment on any of the available cancer tissues
Melanoma
Patients who have had a biopsy of at least one lesion or who are planned to undergo standard-of-care resection or biopsy of at least one lesion, in order to minimize partial volume effect, the diameter of that lesion should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions.
You may not be if
Patients will not be included in the study if one of the following criteria applies:
Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
Pregnant patients
Breast feeding patients
Patients with abnormal liver (Bilirubin ≥1.5 x ULN, ALT (SGPT) ≥3 x ULN) or kidney function (Serum creatinine clearance ≤50 ml/min as calculated with Cockcroft-Gault formula)
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 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
PART II:
Patients will not be included in the study if one of the following criteria applies:
Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
Pregnant patients
Breast feeding patients
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 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
Clareo Health | Phase I/IIa Study of 68GaNOTA-Anti-MMR-VHH2 for PET/CT
