New PET tracer aims to light up tumors, but trial stalls

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

PART I: Inclusion Criteria: 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. Exclusion Criteria: 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: Inclusion Criteria: 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. Exclusion Criteria: 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