A Phase IIb, Open Label Study for the Detection of Dysplastic Colorectal Polyps during Colonoscopy after EMI-137 Injection in Patients with High Suspicion of Colorectal Cancer. - EMI-137 for detection of dysplastic colorectal polyps

Edinburgh Molecular Imaging Ltd.0 个研究点目标入组 200 人开始时间: 2016年10月26日最近更新: 2019年11月25日

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•1.Signed informed consent prior to any study-mandated procedure;
•2.Healthy male or female subjects aged 18 years or older;
•3.Female subjects need to be either surgically sterile (has had a documented bilateral
•oophorectomy and/or documented hysterectomy), post-menopausal (cessation of
•menses for more than 1 year), or pre-menopausal with a negative urine pregnancy test
•performed at screening and a negative urine pregnancy test performed within 24 hours
•of administration of EMI-137 Injection. Pre-menopausal female subjects should also
•employ an effective method of birth control up to 90 days after EMI-137 administration. Barrier contraceptives must be used throughout the study in both sexes.
•4.The subject has a positive FOB test or clinical suspicion on colorectal cancer and is scheduled to undergo a colonoscopy.
•5.The subject has a normal or clinically acceptable medical history, physical examination,
•and vital signs findings at screening (within 21 days prior to administration of study
•6.The subject’s screening ECG and clinical laboratory tests are within normal limits, or if
•any are outside of normal limits they are considered to be clinically insignificant.
•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 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•1.If female, the subject is lactating or pregnant.
•2.The subject is being treated or has been treated with chemotherapy or radiation within the 3 months before enrolment.
•3.A biopsy has been obtained from the colon within the 3 weeks before enrolment.
•4.The subject has been previously included in this study.
•5.Treatment with another IMP within 3 months prior to screening or more than 4 times in
•the past year.
•6.Loss of blood outside the limits of Sanquin within 3 months prior to screening.
•7.The subject has had any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to EMI-137 administration.
•8.The subject has a history of alcohol and/or drug abuse within the previous 12 months, based on a review of medical records.

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