Patients diagnosed with non-small cell lung cancer (NSCLC), planned for standard-of-care (SOC) surgery
Conditions
Interventions
Product Name: 68Ga-NOTA-Anti-MMR-VHH2
Pharmaceutical Form: Solution for injection
INN or Proposed INN: anti-MMR-VHH2
Other descriptive name: Nanobody against macrophage mannose receptor, conjugated wi
Sponsors
UZ Brussel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients who have given informed consent - Patients at least 18 years old - 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 minimize partial volume effect the diameter of the tumor 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. - 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. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher. - Pregnant patients - Breast feeding patients - Patients with any serious active infection - Patient 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 best radiopharmaceutical - Patients who are unlikely to cooperate with the requirements of the study - Patients who are unwilling and/or unable to give informed consent - Patients with increased risk of death from a pre-existing concurrent illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (1) To correlate uptake of 68GaNOTA-Anti-MMR-VHH2 with the expression of MMR using immunohistology (2) To evaluate tumour uptake of 68GaNOTA-Anti-MMR VHH2 in patients with NSCLC ;Secondary Objective: Extended safety assessment of 68GaNOTA-Anti-MMR-VHH2 ;Primary end point(s): Immunohistological MMR score on excised tissue;Timepoint(s) of evaluation of this end point: Evaluations will be done in batch analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Belgium
Contacts
Public ContactTony Lahoutte
UZ Brussel
Outcome results
None listed