NCT02587247已完成2 期
Apport de l'Immuno-TEP préciblée Avec l'Anticorps bispécifique Anti-ACE x Anti-HSG TF2 et le Peptide IMP-288 marqué au Gallium-68 Pour l'Imagerie Des Patients Potentiellement Candidats à Une Chirurgie d'exérèse et/ou Thermoablation Locale d'Une ou Plusieurs métastases, au Diagnostic ou Lors de la Rechute de Cancers Colo-rectaux (CCR) Exprimant l'antigène Carcino-embryonnaire (ACE): Comparaison au Bilan Conventionnel
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Evaluate the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68
研究概览
简要总结
Evaluation of the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68 for imaging potential candidate patients for surgery of local resection of one or more metastases at diagnosis or during relapse CCR expressing CEA.
详细描述
Injection of a bispecific anti-CEA x anti-HSG antibody TF2 (120 nmoles) and 30 hours later IMP-288 peptide labeled with gallium-68 (3 to 6 nmoles/150 MBq). A TEP imaging acquisition is plannified 60 min after the 68-Ga injection.
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
- •Existence of one or more metastases of of colorectal cancer (CRC) expressing the CEA , potentially accessible by surgical or thermo resection at the moment of the diagnosis or at relapse.
- •Isolated and progressive elevation of plasma CEA during the monitoring of CRC with high metastatic risk
- •More than 18 years
- •Negative pregnancy test for women of childbearing age. Women of childbearing age should take effective continuous contraception for 3 months.
- •At least 4 weeks after the last treatment and after recovery of potential toxicity
- •Karnofsky more than 70 or ECOG 0-1
- •Life expectancy of at least 6 months
- •CEA positive immunohistochemistry or plasma CEA supperior or equal to the normal level
- •Creatinin less or equal 200 micromol/L
- •Signed informed consent
- •geographical proximity
排除标准
- •Pregnancy or breastfeeding
- •Serious illness or comorbidity assessed risk
- •History of other cancer within 5 years, with the exception of skin carcinomas other than melanomas or in-situ carcinoma of the cervix
- •Anti-antibody presence in patients who have already received antibody
- •Hypersensitivity to antibodies or proteins
- •Intellectual inability to sign the informed consent
- •Insulin-dependent diabetic patient or non-insulin dependent
研究组 & 干预措施
TF2 antibody/68Ga-IMP-288
Experimental
TF2 antibody/68Ga-IMP-288
干预措施: TF2 antibody/68Ga-IMP-288 (Drug)
结局指标
主要结局
Evaluate the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68
时间窗: Month 3
Initial and M3 imaging assessment comparaison, and/or immunohistochemistry
次要结局
- To compare the diagnostic performance of immuno-PET with morphological and functional imaging procedures currently performed in the imaging assessment (CT, ultrasound + liver MRI, FDG-PET).(Month 3)
- To Determine the value of immuno-PET in terms of specificity and predictive value. This determination will be made at the "patient" and at the "injury level.(Month 3)
- To assess the safety of the procedure(Month 3)
- Search for the development of a blood Immunization against the products(Month 3)
- To study the expression of CEA intensity on surgical excision parts in surgical patients and compare it to the semi-quantitative immuno-PET(No more than 3 months (it depend of the day of the surgery))
- To evaluate the clinical impact (new lecture of imaging, new examens)(M1)
研究者
研究点 (4)
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