Pilot Study for Optimization of Immuno-PET Pretargeted With Anti-CEA Bispecific Antibody X Anti-HSG TF2 and the Peptide IMP-288 Radiolabeled With Gallium-68 -Pharmacokinetic and Imaging for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- evaluation of the tumor targeting (no Unit) and signal / noise ratio (no unit) by the immunoTEP with TF2 and 68-Ga-IMP-288
研究概览
简要总结
Main objective: To determine the optimal molar doses of the biospecific antibody TF2 and 68 Ga-IMP-288 and the optimal time for pretargeting for immuno-PET in patients with breast carcinoma.
Secondary objectives: To study the sensitivity of the immuno-PET, compare its performance to standard imaging methods, evaluate the safety of 150 MBq of 68 Ga-IMP-288; study the development of immunization against TF2 or complex TF2-IMP-288;
详细描述
- 4 or 5 cohorts of 3 patients receiving different doses of TF2 IMP-288 with different interval time. A last cohort (4 or 5 ): maximum of 21 additional patients with the optimal schedule.
Cohort I: TF2 120 nmol / 6 nmol IMP-288 / 24 hours
Cohort II: based on the results of the cohort I :
- Good signal of the tumor but high background: increased interval time, 120 nmol TF2 / 6 nmol of IMP-288 / 30 hours
- Low signal of the tumor: reduction of the interval time, 120 nmol TF2 / 6 nmol IMP-288 / 18 hours
- Good signal of the tumor and good background signal : dose reduction, 60 nmol TF2 / 3nmol IMP- 288 / 24 hours
Cohort III: based on results of cohort II:
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast carcinoma, HER2 + (Dako) and HER2 + (fish) metastatic at least after treatment with current consensus
- •≥ 18 years
- •Negative pregnancy test for women of childbearing age. Women of childbearing age should take effective contraception continuously for 3 months.
- •Karnofsky ≥ 70 or ECOG 0-1
- •• ACE of the tumor by immunohistochemistry or positive plasma CEA ≥ 10 ng / mL
- •At least one measurable lesion on CT
- •creatinine < 2.5
- •Informed consent signed
- •Social insurance
排除标准
- •Pregnancy or breastfeeding
- •Serious illness or co-morbidity risk assessed
- •History of cancer within 5 years except skin cancer other than melanoma or carcinoma in situ of the cervix
- •Presence of anti-antibodies in patients who have previously received antibodies
- •Known hypersensitivity to antibodies or proteins
- •intellectual disability to sign the informed consent
- •Not controlled diabetes
- •Persons protected by law
结局指标
主要结局
evaluation of the tumor targeting (no Unit) and signal / noise ratio (no unit) by the immunoTEP with TF2 and 68-Ga-IMP-288
时间窗: One week
Pk blood after injections of TF2 and 68 Ga-IMP-288 and PET imaging semi-quantification with 60 to 120 minutes after injection of 68 Ga-IMP-288
次要结局
- Sensibility, tolerance(6 months after immunoTEP)
- To study the contribution of immnoTEP to assess early response to treatment, compare its performance to standard imaging methods(month 6)