Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Advanced Accelerator Applications
A total of 50 subjects were planned for the study (10 subjects for the dosimetry group and 40 subjects for the non dosimetry group). In total, 22 subjects were screened for eligibility and 19 subjects were enrolled (2 subjects in the dosimetry group and 17 subjects in the non dosimetry group).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects must be at least 18 years of age
Subjects must have signed and dated an informed consent prior to any study-specific procedures
Subjects with histologically-confirmed tumor for whom a recent biopsy (not older than 6-months old) has been performed.
Dosimetry group: luminal breast cancer, adenocarcinoma of the prostate
Non-dosimetry group: luminal breast cancer, adenocarcinoma of the prostate, small cell lung cancer, non-small cell lung cancer, colorectal carcinoma
At least one malignant lesion detected via functional or morphological imaging (PET combined to appropriate tracer according to tumor type, CT, MRI) within 3 months prior to \[68Ga\]-NeoBOMB1 administration
The Eastern Cooperative Oncology (ECOG) performance status 0-2.
Subjects must agree to use highly effective methods of contraception (female partners of male participants should use highly effective methods of contraception) during the trial.
participation in any other investigational trial within 30 days of study entry
subjects with positive pregnancy test (urine dipstick), and/or currently breast-feeding
concurrent severe illness or clinically relevant trauma within 2 weeks before the administration of the investigational product that might preclude study completion or interfere with study results
concurrent bladder outflow obstruction or unmanageable urinary incontinence
known or expected hypersensitivity to \[68Ga\]-NeoBOMB1 or any excipient present in \[68Ga\]-NeoBOMB1
any condition that precludes raised arms position
prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide
history of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
