NL-OMON46627
Not Yet Recruiting
Phase 2
Phase II study of preliminary diagnostic performance of [68Ga]-NeoBOMB1 in adult patients with malignancies known to overexpress Gastrin Releasing Peptide Receptor - A68GA201
Advanced Accelerator Applications International S.A.0 sites10 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Advanced Accelerator Applications International S.A.
- Enrollment
- 10
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Renal insufficiency or an estimated Glomerular Filtration Rate (eGFR) \<50 ml/min/1\.73m2\..
- •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.
Outcomes
Primary Outcomes
Not specified
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