Prospective Phase II Pilot Study, Assessing Imaging Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT (Positron Emission Tomography/Computerized Tomography) in Metastatic Triple Negative Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT
研究概览
简要总结
The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT tracer for the imaging of metastatic triple negative breast cancer (TNBC) patients.
详细描述
The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, Carbonic Anhydrase IX (CAIX) targeted PET/CT tracer for the imaging of metastatic triple negative breast cancer (TNBC) patients.
TNBC patients are known to be rapidly progressive and have a poor prognosis. This poor prognosis is due to the lack of common breast cancer targets in TNBC. As TNBC expresses CAIX, this stuy will evaluate CAIX targeting by using a radiolabeled monoclonal antibody that recognizes carbonic anhydrase IX (CAIX) : 89Zr- girentuximab otherwise known as 89Zr-TLX250. Previous and ongoing studies have demonstrated the potential application of 89Zr-TLX250 as a new PET/CT imaging tracer for the detection of renal cancer.
After establishing the TNBC targeting properties of the 89Zr-TLX250 PET/CT imaging tracer, it should be interesting to develop a new targeted therapy using TLX250- radiolabeled with a therapeutic radionuclide such as 177Lutétium.
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
- •Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
- •Female or male, Age ≥ 18 years at time of study entry.
- •Primitive triple negative breast cancer proven histologically, defined according to the following criteria:
- •Estrogen receptors <10%.
- •And progesterone receptors <10%.
- •And Human Epidermal Growth factor Receptor 2 (HER2) not amplified or not overexpressed.
- •Breast Cancer (BC) recurrence documented by conventional imaging and/or FDG PET/CT with at least one measurable metastatic lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) and/or PET Response Criteria In Solid Tumors (PERCIST).
- •Consent to use a contraception method for at least 30 days after administration of 89Zr-TLX
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or
- •Life expectancy at least 6 months.
- •Patient has valid health insurance.
- •Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
排除标准
- •History of another primary malignancy except for basal cell carcinoma within the last 5 years.
- •Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or continuing adverse effects (> grade 1) from such therapy (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
- •Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
- •Exposure to murine or chimeric antibodies within the last 5 years.
- •Previous administration of any radionuclide within 10 half-lives of the same.
- •Impossibility to hold lying motionless at least 1 hour, or known claustrophobia.
- •Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator.
- •Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- •Pregnant or likely to be pregnant or nursing patient.
- •Known hypersensitivity to girentuximab or desferoxamine.
- •Renal insufficiency with Glomerular Filtration Rate : GFR ≤ 45 mL/min/ 1.73 m².
- •Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.
- •Disorder precluding understanding of trial information or informed consent.
研究组 & 干预措施
89Zr-TLX250 PET/CT
89Zr-TLX250 PET/CT
干预措施: 89Zr-TLX250 (Drug)
结局指标
主要结局
Number of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT
时间窗: 5 days
The number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CT is reported to assess the concordance for tumor lesion detection using 89Zr-TLX250 PET/CT and 18FDG) PET/CT
Number of Breast Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
时间窗: 5 days
Number of breast lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
Number of Bone Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
时间窗: 5 days
Number of bone lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
Number of Lymph Nodes Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
时间窗: 5 days
Number of lymph nodes lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
Number of Liver Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
时间窗: 5 days
Number of liver lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
Number of Lung Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
时间窗: 5 days
Number of lung lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
Number of Brain Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
时间窗: 5 days
Number of brain lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and 18FDG PET/CT. The detection performance of 89Zr-TLX250 PET/CT and 18FDG PET/CT for identifying brain lesions has been compared.
次要结局
- Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT(5 days)
- Number of Patient With Concordance Between the 89Zr-TLX250 PET/CT Uptake and CAIX Histological Expression(5 days)
- Number of Participants With Adverse Events Related to 89Zr-TLX250(30 days)
- Number of Participants With Serious Adverse Events Related or Not to 89Zr-TLX250(30 days)