NCT04561492进行中（未招募）2 期
Exploratory Study Evaluating the Relevance of [68Ga]Ga -PentixaFor for Initial Staging and Therapeutic Evaluation of Symptomatic Multiple Myeloma Patients in First Line Treatment or in Relapse
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 8
- 主要终点
- To determine the sensitivity of [68Ga]Ga-PentixaFor-PET to detect Multiple Myeloma (MM) lesions [Bone marrow (BM) lesions and/or extra-medullary disease (EMD) ] at the time of initial diagnosis or at relapse.
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 therapeutic evaluation of symptomatic multiple myeloma patients in first line treatment or in relapse. 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Symptomatic MM patients according to IMWG criteria (12) requiring first-line treatment
- •Written and signed informed consent (obtained on the screening day at the latest and before any investigation)
- •ECOG (Eastern Cooperative Oncology Group) < 2
- •Patient affiliated to or beneficiary of the National Health Service
排除标准
- •HIV positive, active Hepatitis B or C
- •Childbearing or child breast feeding women
- •Women or men without effective contraceptive barrier if needed
- •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
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Known active infection
- •Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus
- •Patient under guardianship or trusteeship
- •Patient under judicial protection
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
To determine the sensitivity of [68Ga]Ga-PentixaFor-PET to detect Multiple Myeloma (MM) lesions [Bone marrow (BM) lesions and/or extra-medullary disease (EMD) ] at the time of initial diagnosis or at relapse.
时间窗: 1 Month
Sensitivity will be assessed by patient and lesion analysis by defining: * True positive (TP): * lesion positive with \[68Ga\]Ga-PentixaFor-PET and positive by FDG-PET * or lesion positive with \[68Ga\]Ga-PentixaFor-PET, negative on FDG-PET but confirmed by another CT scan/ MRI or histology, or confirmed by follow-up (until therapeutic evaluation). * False negative (FN): - lesion negative with \[68Ga\]Ga-PentixaFor-PET and positive by FDG-PET and confirmed by CT or MRI or histology, or confirmed by follow-up.
次要结局
- To determine at the time of therapeutic evaluation the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET and if available their link with histology.(100 Day or 6 Month)
- To determine at the time of therapeutic evaluation the prognostic impact of FDG PET and [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique.(Every 6 months after the end of treatment)
- To determine at the time of therapeutic evaluation the link between PET-FDG, [68Ga]Ga-PentixaFor-PET results and minimal residual disease evaluated by flow cytometry(100 Day or 6 Month)
- To determine at the time of therapeutic evaluation the tolerance of [68Ga]Ga-PentixaFor-PET(100 Day or 6 Month)
- To determine at the time of initial diagnosis or at relapse, the specificity, the positive predictive value (PPV) and negative predictive value (NPV) of [68Ga]Ga-PentixaFor-PET(1 Month)
- To determine at the time of initial diagnosis or at relapse, the prognostic impact of FDG PET and of [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique(1 Month)
- To determine at the time of initial diagnosis or at relapse, the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET(1 Month)
- To determine at the time of initial diagnosis or at relapse, the factors associated with discrepancies between FDG PET and [68Ga]Ga-PentixaFor-PET(1 Month)
- To determine at the initial diagnosis or relapse, the correlation between PET-FDG and [68Ga]Ga-PentixaFor-PET uptakes evaluated by SUV and the cytogenetic data evaluated on the myelogram (particularly the measurement of the expression of the gene coding(1 Month)
- To determine at the time of initial diagnosis or at relapse, the tolerance of [68Ga]Ga-PentixaFor-PET(1 Month)
- To determine at the time of therapeutic evaluation the prognostic impact of FDG PET and [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique.(100 Day and 6 Month)
研究者
研究点 (8)
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