Clinical trial • Phase II • Oncology
NANOBODY AGAINST MACROPHAGE MANNOSE RECEPTOR, CONJUGATED WITH 1,4,7-TRIAZACYCLONONANE-N,N',N''-TRIACETIC ACID, LABELLED WITH GALLIUM GA-68 for Non-small cell lung cancer
Phase II trial of NANOBODY AGAINST MACROPHAGE MANNOSE RECEPTOR, CONJUGATED WITH 1,4,7-TRIAZACYCLONONANE-N,N',N''-TRIACETIC ACID, LABELLED WITH GALLIUM GA-…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer
- Trial Stage
- Phase II
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 16-10-2024
- First CTIS Authorization Date
- 28-10-2024
Trial design
None/Not specified-controlled Phase II trial across 1 site in Belgium.
- Comparator
- None/Not specified
- Target Sample Size
- 20
Eligibility
Recruits 20 No vulnerable population selected. Study requires informed consent from each participant ("Patients who have given informed consent"); patients unwilling or unable to give informed consent are excluded. No paediatric consent or assent procedures described (study restricted to patients at least 18 years old)..
- Pregnancy Exclusion
- Pregnant patients
- Vulnerable Population
- No vulnerable population selected. Study requires informed consent from each participant ("Patients who have given informed consent"); patients unwilling or unable to give informed consent are excluded. No paediatric consent or assent procedures described (study restricted to patients at least 18 years old).
Inclusion criteria
- {"criterion_text":"- Patients who have given informed consent\n- Patients at least 18 years old\n- Patient with local, locally advanced or metastatic disease of lung cancer, who is planned for resection or surgical biopsy of at least one lesion. In order to minimise partial volume effect, the diameter of the tumour to be resected or biopsied should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions\n- Patients who participated already in this study can be included if the subject meets all of the inclusion and none of the exclusion criteria at time of second inclusion."}
Exclusion criteria
- {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher\n- Pregnant patients\n- Breast feeding patients\n- Patients with any serious active infection\n- 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\n- Patients who are unlikely to cooperate with the requirements of the study\n- Patients who are unwilling and/or unable to give informed consent\n- Patients at increased risk of death from a pre-existing concurrent illness"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Immunohistological MMR score on excised tissue","definition_or_measurement_approach":"Immunohistological MMR-staining of the excised lesion; primary objective is to correlate uptake of 68GaNOTA-AntiMMR-VHH2 in a NSCLC lesion before surgery with the immunohistological MMR-staining (MMR score) of the excised lesion."}
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 46
- Consent Approach
- Informed consent required from each patient. Adults only ("Patients at least 18 years old"). Subject Information Sheets and Informed Consent Forms for adults are provided in Dutch (NL), French (FR) and English (ENG) (documents: SIS and ICF adults_NL_redacted, SIS and ICF adults_FR_redacted, SIS and ICF adults_ENG_redacted). No assent or paediatric consent described.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 20
Belgium
- Latest Decision Or Authorization Date
- 18-04-2025
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- UZ Brussel
- Department Name
- Nuclear Medicine
- Principal Investigator Name
- Tony Lahoutte
- Principal Investigator Email
- nucg.clinicaltrials@uzbrussel.be
- Contact Person Name
- Tony Lahoutte
- Contact Person Email
- nucg.clinicaltrials@uzbrussel.be
Sponsor
Primary sponsor
- Full Name
- UZ Brussel
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- 68Ga-UZBRU-VHH2
- Active Substance
- NANOBODY AGAINST MACROPHAGE MANNOSE RECEPTOR, CONJUGATED WITH 1,4,7-TRIAZACYCLONONANE-N,N',N''-TRIACETIC ACID, LABELLED WITH GALLIUM GA-68
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- INTRAVENOUS ADMINISTRATION
- Maximum Dose
- 370 MBq
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