bowel polyps dysplastic colorectal polyps
Conditions
Interventions
fluorescence guided colonoscopy after EMI-137 administration.
Detection
Dysplastic colorectal polyps
Sponsors
Edinburgh Molecular Imaging Ltd.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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 35 days prior to administration of study drug). 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.
Exclusion criteria
Exclusion criteria: 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 or another fluorescence IMP. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Detection of additional pathological lesions using WL+ FL compared to WL only - Fluorescence signal of lesions - TBR signal, defined as fluorescent signal of the lesion compared to fluorescence signal of tissue surrounding the lesion - Concordance of fluorescence intensity and lesions with different pathological lesion statuses and C-Met expression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability endpoints - Treatment-emergent (serious) adverse events ((S)AEs). - Concomitant medication - Clinical laboratory tests o Haematology o Chemistry o Urinalysis - Vital signs o Pulse Rate (bpm) o Systolic blood pressure (mmHg) o Diastolic blood pressure (mmHg) o Body temperature ( *C ) - Presence of injection site reactions Pharmacokinetic endpoints Pharmacokinetics will be assessed by a single, in vivo, spectroscopy derived, quantitative measurement of the lesion (target) and normal bowel tissue (background). These parameters will later be converted to a target to background ratio. | — |
Countries
The Netherlands
Outcome results
None listed