Dysplastic Colorectal Polyps MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: EMI-137
Product Code: EMI-137
Pharmaceutical Form: Powder for injection
INN or Proposed INN: EMI-137
CAS Number: N.A.
Sponsors
Edinburgh Molecular Imaging Ltd.
Eligibility
Sex/Gender
All
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 21 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. 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
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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of 0.13mg/kg EMI-137 IV injection to detect lesions during colonoscopy, in subjects at high suspicion of developing colorectal cancer by: - Comparing the number of pathological lesions detected with WL with the number of lesions detected with WL+FL - Investigating the concordance of fluorescence intensity, C-Met expression and histologic status. - Establishing target to background ratio (TBR) of fluorescent lesions. ; Secondary Objective: • To assess the safety and tolerability of 0.13mg/kg EMI-137 iv injection; • To assess the practical application of the technique, eg. - Ease of use of the SurgVision Explorer Endoscope camera system (SVEE); - Ease of use of EMI-137 for injection; • To assess the tissue pharmacokinetics of a single IV injection of 0.13mg/kg EMI-137 by in vivo quantification of fluorescence signals in polyps and normal tissue by spectroscopy; • To assess the optimal time window between dose administration and fluorescence imaging (stage 1); • To assess c-MET expression and fluorescence on fluorescence microscopy in biopsied lesions. ; Primary end point(s): Efficacy - 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 between fluorescence, tumor status and C-Met expression. ; Timepoint(s) of evaluation of this end point: - Interim analysis: after 15 colonoscopies in stage 2 - End of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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. ;Timepoint(s) of evaluation of this end point: In-study analysis of optimal time-window after inclusion of 15 patients, other outcomes: after end of study | — |
Countries
Netherlands
Contacts
Public ContactJ. Burggraaf
CHDR
Outcome results
None listed