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.
- Conditions
- 10017998dysplastic colorectal polypsbowel polyps10017991
- Registration Number
- NL-OMON47367
- Lead Sponsor
- Edinburgh Molecular Imaging Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Detection of additional pathological lesions using WL+ FL compared to WL only<br /><br>- Fluorescence signal of lesions<br /><br>- TBR signal, defined as fluorescent signal of the lesion compared to<br /><br>fluorescence signal<br /><br>of tissue surrounding the lesion<br /><br>- Concordance of fluorescence intensity and lesions with different pathological<br /><br>lesion statuses and C-Met expression.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety and tolerability endpoints<br /><br>- Treatment-emergent (serious) adverse events ((S)AEs).<br /><br>- Concomitant medication<br /><br>- Clinical laboratory tests<br /><br>o Haematology<br /><br>o Chemistry<br /><br>o Urinalysis<br /><br>- Vital signs<br /><br>o Pulse Rate (bpm)<br /><br>o Systolic blood pressure (mmHg)<br /><br>o Diastolic blood pressure (mmHg)<br /><br>o Body temperature ( *C )<br /><br>- Presence of injection site reactions<br /><br><br /><br>Pharmacokinetic endpoints<br /><br>Pharmacokinetics will be assessed by a single, in vivo, spectroscopy derived,<br /><br>quantitative measurement of the lesion (target) and normal bowel tissue<br /><br>(background). These parameters will later be converted to a target to<br /><br>background ratio.</p><br>