2024-517658-90-00招募中1 期
ProspectivE phase 0 pilot study, assessing potential prognostic and theranostic interest of 68Ga-PentiXafor PET-CT In metastatic triple neGative brEast caNCer patiEnts (EXIGENCE)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Concordance study of metastatic uptake seen in [18F]FDG PET/CT scan and [68Ga]Ga-PentixaFor PET/CT scan per "lesion" by comparing for each lesion the [18F]FDG PET scan and [68Ga]Ga-PentixaFor PET/CT scan by assessing a ratio "Number of positive or negative [68Ga]Ga-PentixaFor lesions / Number of positive or negative FDG lesions” performed at patient inclusion.
研究概览
简要总结
To assess the concordance for tumor lesion detection with [68Ga]Ga-PentixaFor PET/CT and [18F]FDG PET/CT based on a lesion-by-lesion basis analysis performed at patient inclusion.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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
- •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
- •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 HER2 not amplified or not overexpressed
- •Recurrence metastatic Breast Cancer or De Novo metastatic Breast Cancer documented by [18F]FDG PET/CT ± conventional imaging with at least one measurable metastasis according to PERCIST and/or RECIST
- •ECOG performance status <
- •Negative serum/urine pregnancy test prior to [68Ga]Ga-PentixaFor administration.
- •Consent to use a contraception method for at least 3 months after each administration of [68Ga]Ga-PentixaFor.
- •Adequate Organ function confirmed by laboratory tests results allowing for safe administration of [68Ga]Ga-PTF
- •Life expectancy at least 3 months.
排除标准
- •History of another primary malignancy within the last 3 years except for basal cell carcinoma.
- •Body weight of less than 48 kg
- •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
- •Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first [68Ga]Ga-PTF administration
- •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, likely to be pregnant or breastfeeding woman
- •Unstable diabetes with blood glucose > 2 g/L
- •Renal insufficiency with GFR ≤ 45 mL/min/ 1.73 m².
- •Known hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PentixaFor and/or [18F]FDG product
结局指标
主要结局
Concordance study of metastatic uptake seen in [18F]FDG PET/CT scan and [68Ga]Ga-PentixaFor PET/CT scan per "lesion" by comparing for each lesion the [18F]FDG PET scan and [68Ga]Ga-PentixaFor PET/CT scan by assessing a ratio "Number of positive or negative [68Ga]Ga-PentixaFor lesions / Number of positive or negative FDG lesions” performed at patient inclusion.
Concordance study of metastatic uptake seen in [18F]FDG PET/CT scan and [68Ga]Ga-PentixaFor PET/CT scan per "lesion" by comparing for each lesion the [18F]FDG PET scan and [68Ga]Ga-PentixaFor PET/CT scan by assessing a ratio "Number of positive or negative [68Ga]Ga-PentixaFor lesions / Number of positive or negative FDG lesions” performed at patient inclusion.
次要结局
- Concordance study of metastatic uptake seen in [18F]FDG PET/CT scan and [68Ga]Ga-PentixaFor PET/CT scan per "lesion" by comparing for each lesion the [18F]FDG PET/CT scan and [68Ga]Ga-PentixaFor PET/CT scan by assessing a ratio "Number of positive or negative [68Ga]Ga-PentixaFor lesions / Number of positive or negative FDG lesions” performed at disease progression.
- Conventional imaging (CT scan), and [68Ga]Ga-PentixaFor PET/CT will be analysed for each lesion, obtaining a ratio of number of [68Ga]Ga-PentixaFor(+) lesions / number of CT scan lesions" at patient inclusion.
- Conventional imaging: CT scan, and [68Ga]Ga-PentixaFor PET/CT will be analysed for each lesion, obtaining a ratio of number of [68Ga]Ga-PentixaFor(+) lesions / number of CT scan lesions" at disease progression.
- Percentage of [68Ga]Ga-PentixaFor(+) metastatic tumor burden compared to total metastatic tumor burden by [18F]FDG PET/CT .
- Assess the correlation between the standard uptake values (SUV) of [68Ga]Ga-PentixaFor and IHC CXCR4 expression, by comparing the [68Ga]Ga-PentixaFor semi-quantitative data with the CXCR4 expression results of biopsied metastases at screening and at disease progression if biopsy is performed.
- The tolerance of [68Ga]Ga-PentixaFor will be checked by measuring and monitoring vital signs for 60 minutes after [68Ga]Ga-PentixaFor administration. The patient will be informed that in the event of abnormal physical signs, occurring within 48 hours after [68Ga]Ga-PentixaFor administration, he (she) must inform the investigator for registration. The CTC-NCI Common Toxicity Criteria, version 5.0 reference will be used.
研究者
Dr Caroline ROUSSEAU
Scientific
Institut De Cancerologie De L Ouest
研究点 (1)
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