Pharmacokinetic and Imaging Optimization Study of Pretargeted Immuno-PET Using the Anti-CEA x Anti-HSG TF2 Bispecific Antibody and 68Ga-IMP-288 Peptide in Patients With Recurrences of Medullary Thyroid Carcinoma.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288
研究概览
简要总结
The aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion
详细描述
Variation of TF2 molar dose, IMP-288 molar dose and pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 30 to 120 nmol of TF2 and 1.5 to 6 nmol of peptides 1 to 3 days apart. Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections.
A last cohort (cohorte number 5 or 6) with optimal conditions will be proposed. Whole-body PET images will be recorded 60 and 120 minutes after 68Ga-IMP-288 injection to assess semi-quantitatively tumor targeting and tumor/background ratio. Moreover, the targeting sensitivity of the TF2-pretargeted 68Ga-IMP-288 will be compared to standard methods of tumor.
some patient will have a second immuno-TEP for their follow up in the first examen was the most sensible.
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
- •Histological diagnosis of CMT
- •Calcitonin> 150 pg / ml
- •Complete treatment of the primary tumor
- •at least one detectable lesion more than 10 mm on conventional imaging: bone lesions can be taken into account if they extend outside of the bone and the party extra bone is measurable.
- •Age ≥ 18 years
- •Negative pregnancy test for women of childbearing age in the previous 2 days immuno-PET. Women of childbearing potential should use effective contraception take continuously for 3 months.
- •KPS ≥ 70 or ECOG 0-1 and life expectancy of at least 6 months
- •Absence of serious illness or co-morbidity assessed risk
- •Creatinine ≤ 2.5 normal
- •Absence of cancer treatment within 6 weeks prior to the immuno-PET
- •No history of cancer within 5 years, except skin cancer other than melanoma or carcinoma in situ of the cervix
- •Lack of anti-antibodies in patients who have previously received antibodies and hypersensitivity to antibody or protein
- •Informed consent signed
- •Social Insurance
排除标准
- •Pregnancy or breastfeeding
- •Serious illness or co-morbidity assessed risk
- •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 antibody or protein
- •Need to establish a cancer treatment within 3 months of immuno-PET (before stock evaluation 3 months)
- •Inability intellectual sign consent
- •Patient protected by law
研究组 & 干预措施
TF2 antibody/68Ga-IMP-288
TF2 coupled with 68 Ga-IMP-288
干预措施: • TF2 and 68 Ga-IMP-288 (Drug)
结局指标
主要结局
Evaluation of the tumor targeting (No Unit) and signal/noise (No Unit)ratio by immunoTEP with TF2 and 68-Ga-IMP-288
时间窗: one week
Decrease of TF2 and IMP- 288 molar doses and variation of pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 120 to 30 nmol of TF2 and 6 à 1.5 nmol of peptides 1 to 3 days apart. A last cohort (number 5 or 6) with optimal conditions will be proposed Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections. Whole-body PET images will be recorded 60 to 120 minutes after 68Ga-IMP-288 injection to assess semiquantitatively tumor targeting and tumor/background ratio.
次要结局
- Sensibilité(6 monts after immunoTEP)