Phase II study of preliminary diagnostic performance of [68Ga]-NeoBOMB1 in adult patients with malignancies known to overexpress Gastrin Releasing Peptide Receptor - Neo-FIND

Advanced Accelerator Applications International SA0 个研究点目标入组 50 人开始时间: 2017年11月17日最近更新: 2019年11月25日

研究概览

暂无简介。

•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 tumour, for whom a less than 6-month-old biopsy 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 tumour type, CT, MRI) within 3 months prior to the administration of [68Ga]-NeoBOMB1.
•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Renal insufficiency or an estimated Glomerular Filtration Rate (eGFR) <50 ml/min/1.73 m2.
•Haematological toxicity grade > 2 (Toxicity Grading Scale in vaccine clinical trials)
•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 68Gallium, 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.

发起方