A phase 1, placebo-controlled, ascending-dose study to assess the safety and imaging characteristics of GE-137 Injection in healthy volunteers, and to assess its safety and imaging characteristics in subjects with high suspicion of colorectal cancer
- Conditions
- Colorectal cancer10017991
- Registration Number
- NL-OMON36432
- Lead Sponsor
- GE Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
Healthy volunteers:
(1) The subject is >=18 and <=70 years old at screening.
(2) Female subjects need to be either surgically sterile, post menopausal or pre menopausal with a negative urine pregnancy test.
(3) The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained before any study-related procedure is performed.
(4)The subject has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening
(5)The subject*s screening ECG and clinical laboratory test results are within normal limits.
(6)The subject has negative test results for drug and alcohol screening.
(7)The subject*s body mass index is <= 30 but not <18 kg/m2.
(8)The subject has negative test results for hepatitis B, hepatitis C, and human immunodeficiency virus.;Subjects with High Suspicion of Colorectal Cancer
(1) The subject is >= 45 years old at screening.
(2) Female subjects need to be either surgically sterile, post menopausal, or pre menopausal with a negative urine pregnancy test
(3) The subject has high suspicion of CRC.
(4) The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained before any study-related procedure is performed.
(5) The subject has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening .
(6)The subject*s screening ECG and clinical laboratory tests are within normal limits.
(7)The subject*s body mass index is <=30 but not <18 kg/m2.
Healthy Volunteers
(1) If female, the subject is lactating or pregnant.
(2) The subject has been previously included in this study.
(3) Treatment with another investigational medicinal product (IMP) within 3 months prior to screening or more than 4 times in the past year.
(4) Loss of blood outside the limits of Sanquin within 3 months prior to screening.
(5) The subject has received any prescription or non-prescription medication regularly between 14 days and 1 day prior to IMP administration. Occasional use of analgesics, such as ibuprofen and paracetamol, etc., is permitted at the discretion of the investigator. Use of hormonal contraceptives is also permitted. ;Subjects with High Suspicion of Colorectal Cancer
(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 IMP administration. Occasional use of analgesics, such as ibuprofen and paracetamol, etc., is permitted at the discretion of the investigator. Use of hormonal contraceptives is also permitted.
(8) The subject has a history of alcohol and/or drug abuse within the previous 12 months, based on a review
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety of GE-137 in healthy volunteers and patients with high suspicion of<br /><br>colorectal cancer, using standard safety measures</p><br>
- Secondary Outcome Measures
Name Time Method <p>-To detemine the optimal dose of GE-137 and the optimal timing between GE-137<br /><br>dosing and endoscopy.<br /><br>-To determine if GE-137 detects areas of increase fluorescence in the colon<br /><br>that correlate with pathology and c-Met expression in patients with high<br /><br>suspicion of CRC</p><br>