NCT05933239招募中2 期
A Phase II Study to Evaluate the Imaging Potential of 68GaNOTA-Anti-MMR VHH2 for in Vivo Imaging of MMR-expressing Macrophages by Means of Positron Emission Tomography (PET) in Patients With Non-small Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Correlation of uptake of 68GaNOTA-Anti-MMR-VHH2 in a NSCLC lesion before surgery with the immunohistological MMR-staining of the excised lesion.
研究概览
简要总结
Phase II study to evaluate the clinical potential of 68GaNOTA-anti-MMR-VHH2 for in vivo imaging of Macrophage Mannose Receptor (MMR)-expressing Macrophages by means of Positron Emission Tomography (PET) in patients with non-small cell lung cancer (NSCLC) planned for surgical resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have given informed consent
- •Patients at least 18 years old
- •Patient with local, locally advanced or metastatic disease of non-small cell 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
- •Patients who participated already in this study can be included if the subject meets all of the inclusion and none of the
排除标准
- •at time of second inclusion.
- •Exclusion Criteria:
- •Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
- •Pregnant patients
- •Breast feeding patients
- •Patients with any serious active infection
- •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
- •Patients who are unlikely to cooperate with the requirements of the study
- •Patients who are unwilling and/or unable to give informed consent
- •Patients at increased risk of death from a pre-existing concurrent illness
研究组 & 干预措施
Patients diagnosed with non-small cell lung cancer (NSCLC), planned for standard-of-care surgery
Other
干预措施: 68GaNOTA-Anti-MMR-VHH2 (Drug)
结局指标
主要结局
Correlation of uptake of 68GaNOTA-Anti-MMR-VHH2 in a NSCLC lesion before surgery with the immunohistological MMR-staining of the excised lesion.
时间窗: Resection of lesion up to 21 days after PET/CT
PET/CT and immunohistochemistry will be assessed using a (semi-)quantitative scale.
次要结局
未报告次要终点
研究者
研究点 (2)
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