EUCTR2017-001471-23-BE进行中（未招募）1 期
Phase I/IIa study to evaluate the safety, biodistribution, radiation dosimetry and tumor imaging potential of 68GaNOTA-Anti-MMR-VHH2, a new radiopharmaceutical for in vivo imaging of Tumour-Associated Macrophages by means of Positron Emission Tomography (PET)
Z Brussel0 个研究点目标入组 31 人开始时间: 2018年12月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 31
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients will only be included in the study if they meet all of the following criteria:
- •-Patients who have given informed consent
- •-Patients at least 18 years old
- •- Patient with local, locally advanced or metastatic disease of a malignant solid tumor. In order to minimize partial volume effect the diameter of at least 1 tumor lesion should be = 10 mm in short axis for invaded adenopathies and = 10 mm in long axis for all other types of lesions.
- •Patients will only be included in the study if they meet all of the following criteria:
- •-Patients who have given informed consent
- •-Patients at least 18 years old
- •-Patients diagnosed with a local, locally advanced or metastatic disease, with any of the following cancer types:
- •oTriple-negative breast carcinoma
- •oHormone-receptor negative (HR-), HER2+ breast carcinoma, with HER2-expression defined as HER2+ on ISH or 3+ on IHC, as determined by local assessment on any of the
- •available cancer tissues
- •-Patients who have had a biopsy of at least one lesion or who are planned to undergo standard-of-care resection or biopsy of at least one lesion; in order to minimize partial volume effect, the diameter of that lesion should be = 10 mm in short axis for invaded adenopathies and = 10 mm in long axis for all other types of lesions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •Patients will not be included in the study if one of the following criteria applies:
- •-Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher.
- •-Pregnant patients
- •-Breast feeding patients
- •-Patients with abnormal liver (Bilirubin =1.5 x ULN, ALT (SGPT) =3 x ULN) or kidney function (Serum creatinine clearance =50 ml/min as calculated with Cockcroft-Gault formula)
- •-Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
- •-Patients with any serious active infection
- •-Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical
- •-Patients who cannot communicate reliably with the investigator
- •-Patients who are unlikely to cooperate with the requirements of the study
- •-Patients who are unwilling and/or unable to give informed consent
- •-Patients at increased risk of death from a pre-existing concurrent illness
- •-Patients who participated already in this study
- •Patients will not be included in the study if one of the following criteria applies:
- •-Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher.
- •-Pregnant patients
- •-Breast feeding patients
- •-Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
- •-Patients with any serious active infection
- •-Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical
- •-Patients who cannot communicate reliably with the investigator
- •-Patients who are unlikely to cooperate with the requirements of the study
- •-Patients who are unwilling and/or unable to give informed consent
- •-Patients at increased risk of death from a pre-existing concurrent illness
- •-Patients who participated already in this study
研究者
相似试验
进行中（未招募）
1 期
Deferoxamine, labelled with radioactive Gallium-68, for diagnosis of bacterial infectionspper/lower respiratory tract bacterial infections or orthopaedic bacterial infectionsEUCTR2020-002868-31-ATMedizinische Universität Innsbruck15
进行中（未招募）
1 期
A Phase I/IIa study to evaluate safety and preliminary diagnostic performance of 68Ga-NeoBOMB1 in patients with advanced Tyrosine-kinase inhibitorstreated Gastrointestinal stromal tumours using positron-emission tomography/computer tomography (PET/CT).Gastrointestinal stromal tumours previously or currently under TKI-treatment including at least 50% TKI-resistant patientsEUCTR2016-002053-38-ATMedical University Innsbruck12
进行中（未招募）
1 期
Minigastrin derivative labelled with radioactive Gallium-68, for the diagnosis of advanced neuroendocrine tumoursAdvanced neuroendocrine tumours (NET), including medullary thyroid carcinoma (MTC), as well as gastroenteropancreatic and bronchopulmonary NETEUCTR2020-003932-26-ATMedizinische Universität Innsbruck12
撤回
2 期
A Phase I/II study to determine the safety and efficacy of a combination of anti-CD3 & anti-CD7 ricin A immunotoxins for treating steroid-resistant acute graft-versus-host disease.GVHDImmuunsysteemaandoeningen: acute omgekeerde afstotingsziekteacute graft-versus-host diseaseNL-OMON31737Henogen S.A.12
已完成
2 期
A Phase I/II study to determine the safety and efficacy of a combination of anti-CD3 & anti-CD7 ricin A immunotoxins (T-Guard) for treating steroid-resistant acute graft-versus-host disease.GVHDNL-OMON44132Xenikos BV10