NL-OMON48394尚未招募不适用
Fluorescence Imaging for the Evaluation of Disease Activity in IBD and Rheumatoid Arthritis using the fluorescent tracer OTL38 targeting the folate B receptor: a single-center pilot study. - Fluorescence imaging of disease activity in IBD and rheumatoid arthritis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Rheumatoid arthritis cohort
- •Start first treatment or treatment switch to (another) biological(s) in a
- •patient diagnosed with active Rheumatoid Arthritis (RA) by their physician in
- •one or both hands.;
- •Age >= 18 years;
- •Written informed consent.,
- •For female subjects who are of childbearing potential, are premenopausal with
- •intact reproductive organs or are less than 2 years postmenopausal
- •A negative pregnancy test must be available
- •Willing to ensure that she or her partner uses effective contraception during
- •the study and for 3 months thereafter.
- •- Patient diagnosed with clinical active ulcerative colitis or Crohn*s disease
- •and therefore scheduled to switch to (another) biological(s);
- •Age >= 18 years;
- •Written informed consent.
- •For female subjects who are of childbearing potential, are premenopausal with
- •intact reproductive organs or are less than 2 years postmenopausal
- •A negative pregnancy test must be available
- •Willing to ensure that she or her partner uses effective contraception during
- •the study and for 3 months thereafter.
排除标准
- •Rheumatoid arthritis cohort
- •Received methotrexate and/or folic acid less than 7 days before tracer
- •Skin type above type 3 according to the Fitspatrick scale;
- •Primary failure (no response) within the first 12 weeks after start with any
- •anti-TNF agent;
- •Prescribed disease modifying anti-rheumatic drugs (DMARDs) at a higher dose
- •than 10 mg and/or no stable dose for at least 4 weeks prior to inclusion;
- •Prescribed oral corticosteroids at a higher dose than 10 mg, and/or no stable
- •dose for at least 4 weeks prior to inclusion;
- •Use of intramuscular or intravenous corticosteroids within 4 weeks prior to
- •Prescribed non-steroidal anti-inflammatory drugs (NSAID) with no stable dose
- •for at least 4 weeks prior to inclusion
- •Concurrent uncontrolled medical conditions according to treating medical
- •Patients with a history of anaphylactic reactions or severe allergies;
- •Patients with a history of allergy to any of the components of OTL38,
- •including folic acid;
- •Treatment with any investigational drug within the previous 3 months.
- •Pregnancy or breast feeding.
- •Concurrent uncontrolled medical conditions;
- •Patients with a history of anaphylactic reactions or severe allergies;
- •Patients with a history of allergy to any of the components of OTL38,
- •including folic acid;
- •Treatment with any investigational drug within the previous 3 months;
- •Pregnancy or breast feeding.
研究者
相似试验
已完成
不适用
Tumor identification using fluorescence imaging: comparison of two imaging systemsliver cancerJPRN-UMIN000023993Graduate school of medicine, University of Tokyo100
进行中（未招募）
2 期
Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor BiomarkerBrain CancerNCT02691923David W. Roberts30
尚未招募
3 期
se of Fluorescence and Reflectance Imaging for diagnosis of abnormalities within the gastrointestinal tractCTRI/2021/01/030415Dr Stanley Mathew
已完成
不适用
Fluorescence and reflectance spectroscopic imaging scan for detection of cervical neoplasiaprecancerous cervical cells10013364Cervical intraepithelial neoplasiaNL-OMON41942niversitair Medisch Centrum Sint Radboud152
进行中（未招募）
不适用
Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance OutcomesBurn WoundNCT05593523University of Wisconsin, Madison100