EUCTR2017-003432-37-AT
Active, Not Recruiting
Phase 1
Phase II study of preliminary diagnostic performance of [68Ga]-NeoBOMB1 in adult patients with malignancies known to overexpress Gastrin Releasing Peptide Receptor - Neo-FIND
ConditionsMalignancies known to overexpress Gastrin-Releasing Peptide ReceptorsMedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10041067 Term: Small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Malignancies known to overexpress Gastrin-Releasing Peptide Receptors
- Sponsor
- Advanced Accelerator Applications International SA
- Enrollment
- 50
- Status
- Active, Not Recruiting
- Last Updated
- 6 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\.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.
Outcomes
Primary Outcomes
Not specified
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