NCT05321862撤回2 期
Exploratory Study Evaluating the Relevance of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation Less Than 66 Years Included in the Prospective IFM 2020-02.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
The aim of our study is to confirm the relevance of PET using [68Ga]Ga-PentixaFor ligand, in comparison with FDG, for initial staging and detection of minimal residual disease in multiple myeloma patients eligible for autologous stem cell transplantation less than 66 years.
The prognostic value of positive CXCR4 expression will also be assessed and [68Ga]Ga-PentixaFor/FDG discordances explored.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria are identical to inclusion criteria in MIDAS study (EudraCT Number: 2020-005216-21, ClinicalTrials.gov Identifier: NCT04934475) .
排除标准
- •Non inclusion criteria are identical to non inclusion criteria in MIDAS study (EudraCT Number: 2020-005216-21, ClinicalTrials.gov Identifier: NCT04934475) added with:
- •eGFR < 50 ml/min by MDRD or CKDEPI.
- •Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years.
- •Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus.
研究组 & 干预措施
[68Ga]Ga-PentixaFor
Experimental
干预措施: [68Ga]Ga-PentixaFor (Drug)
结局指标
主要结局
Sensitivity
时间窗: 6 months
To determine the sensitivity of \[68Ga\]Ga-PentixaFor-PET to detect Multiple Myeloma lesions \[Bone marrow (BM) lesions and/or extra-medullary disease (EMD)\] at the time of initial diagnosis in high risk MM patients included in the MIDAS study.
次要结局
- Specificity, positive predictive value (PPV) and negative predictive value (NPV) of [68Ga]Ga-PentixaFor-PET.(1 month)
- Prognostic impact of FDG-PET and of [68Ga]Ga-PentixaFor-PET depending on the uptake detected by each imaging technique.(1 month)
- Discrepancies rate between FDG-PET and [68Ga]Ga-PentixaFor-PET and factors associated with.(1 month and 6 months)
- Correlation between FDG-PET and [68Ga]Ga-PentixaFor-PET uptakes evaluated by SUV.(1 month)
- Correlation between FDG-PET and [68Ga]Ga-PentixaFor-PET uptakes evaluated by the RNAseq data evaluated on the myelogram.(1 month)
- Prognostic impact of FDG-PET and [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique.(6 months)
- Link between FDG-PET, [68Ga]Ga-PentixaFor-PET results and minimal residual disease evaluated by NGS.(6 months)
- Tolerance of [68Ga]Ga-PentixaFor-PET.(1 month and 6 months)
研究者
研究点 (1)
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