2023-505317-25-00招募中4 期
FAPi-PET imaging of in vivo early fistula healing in perianal Crohn’s disease: PERSIST study
Amsterdam UMC1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年7月28日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- - Visual and quantitative 68Ga-FAPi-46 uptake measurements in and around the perianal fistula at baseline, at follow-up (T1) and the change over both time points
研究概览
简要总结
The feasibility of 68Ga-FAPi-46 PET-CT for fibroblast activation pattern visualization and quantification during early healing of perianal Crohn’s fistulas.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of CD with previously or currently documented luminal inflammation (endoscopy and histopathology)
- •Complex perianal fistula, defined as either involving the upper two-third of the sphincter complex (i.e., high intersphincteric, high transsphincteric, suprasphincteric or extrasphincteric course of the fistula tract), having multiple external openings, are associated with pain or fluctuation suggesting a perianal abscess or are associated with a rectovaginal fistula or anorectal stricture or active rectal ulcers, with active drainage (fluid loss on gentle compression; perianal fistulas that were previously close but that reopened can be included).
- •Age 16 or older
- •Signed informed consent
排除标准
- •Patients with Ulcerative Colitis or IBD-U
- •Presence of impassible anal stricture
- •Superficial or rectovaginal fistula only
- •Patients with ongoing abdominal or undrained perianal abscesses after repeated examination-under-anesthesia with drainage by incision or seton placement
- •Patients with a seton in situ > 12 months
- •Patients with an ostomy
- •Enteric pathogens (such as Salmonella, Shigella, Yersinia, Campylobacter and C. difficile) detected by stool analysis within 2 weeks prior to enrollment or at screening
- •Active or planned pregnancy or lactation Patients previously exposed to two or more anti-TNFs
- •Previously unacceptable side effects or intolerance to all immunosuppressants (both thiopurines and methotrexate) Treatment with vedolizumab or ustekinumab within 30 days
- •Active or latent tuberculosis (screening according to national guidelines)
- •Cardiac failure in NYHA stage III-IV
- •History of demyelinating disease
- •Recent live vaccination (≤ 4 weeks)
- •Patients with ongoing acute/chronic infection (including but not limited to HIV, hepatitis B and C) with the exception of chronic herpes labialis or cervical HPV
- •Male patients with negative EBV serology
- •Patients who received any investigational drug in the past 30 days or 5 half-lives, whichever is longer
- •Patients with a history of colon cancer or colonic dysplasia, unless sporadic adenoma, which has been removed
- •A history of alcohol or illicit drug use that in the opinion of the principal investigator (PI) would interfere with study procedures
- •Patients with psychiatric problems that in the opinion of the PI would interfere with study procedures
- •Patients unable to attend all study visits
- •Participation in a medical intervention trial that interferes with this study in the opinion of the PI
- •Patients with a history of non-compliance with clinical study protocols
结局指标
主要结局
- Visual and quantitative 68Ga-FAPi-46 uptake measurements in and around the perianal fistula at baseline, at follow-up (T1) and the change over both time points
- Visual and quantitative 68Ga-FAPi-46 uptake measurements in and around the perianal fistula at baseline, at follow-up (T1) and the change over both time points
次要结局
- - The best fitting kinetic model to quantify 68Ga-FAPi-46 pharmacokinetics and tracer uptake.
- - The most suitable simplified quantitative measurement as a surrogate for the full kinetic model.
- - The most simplified imaging procedure providing the quantitative measurement correlating to the full kinetic model.
- - Correlate visual and quantitative 68Ga-FAPi-46 uptake measurements in and around the perianal fistula at baseline, at follow-up (week 2 or week 6 or combined) and the change over both time points with clinical and/or radiological response assessments mid- and end-of-treatment (i.e. week 9 and week 26, respectively).
- - Correlate visual and quantitative 68Ga-FAPi-46 uptake measurements in and around the perianal fistula at baseline with clinical and MRI (and eventual endoscopy and pathology if available) parameters at baseline.
研究者
Lieven Mulders, PhD fellow
Scientific
Amsterdam UMC
研究点 (1)
Loading locations...
相似试验
招募中
1 期
FAPi-PET imaging of in vivo early fistula healing in perianal Crohn’s disease: PERSIST studyperianal Crohn's fistulaMedDRA version: 20.0Level: PTClassification code: 10011401Term: Crohn's disease Class: 100000004856MedDRA version: 20.0Level: LLTClassification code: 10075465Term: Fistulizing Crohn's disease Class: 10017947MedDRA version: 20.1Level: LLTClassification code: 10068659Term: Perianal fistula Class: 10017947CTIS2023-505317-25-00Amsterdam UMC10
尚未招募
不适用
68Ga-FAPI PET/CT to detect ongoing fibroblast activity in post-acute COVID-19 with respiratory impairment after hospital discharge: *The FAPI COVID-CLIMATE Study*pulmonary fibrosis - connective tissue formation in the lungs10024970NL-OMON53415niversitair Medisch Centrum Groningen20
招募中
2 期
FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease PatientsIBD (Inflammatory Bowel Disease)Crohn Disease (CD)Ulcerative Colitis (UC)NCT06604260Dalia Lartey20
已完成
不适用
68Ga-FAPI PET/CT to Detect Ongoing Fibroblast Activity in Post-acute COVID-19Post-Acute COVID-19Post-Acute COVID-19 InfectionPost-Acute COVID-19 SyndromePulmonary FibrosisNCT05981885University Medical Center Groningen18
尚未招募
不适用
*[68Ga]FAPI PET/CT to detect fibroblast activity in non-resolving ARDS patients at the ICU*COVID 19ARDSshocklong1004743810024970NL-OMON56625niversitair Medisch Centrum Groningen20