NL-OMON46738
Completed
Not Applicable
Image guided surgery for tumor detection in solid cancers using the pH activated micellar probe ONM-100: The SHINe study - The SHINe study
OncoNano Medicine's Inc.0 sites33 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- OncoNano Medicine's Inc.
- Enrollment
- 33
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Biopsy confirmed diagnosis of primary or recurrent respective tumor type (see section 3\.1\) and scheduled to undergo surgical resection as decided by the respective Multi\-Disciplinary Tumor Boards.
- •o Breast cancer, HNSCC, Esophageal Cancer, Colorectal cancer
- •2\) Age \* 18 years
- •3\) Written informed consent
- •4\) Adequate potential for follow\-up
- •5\) Acceptable hematologic status, kidney function, and liver function, as respective standard surgery protocol requires, as determined by the Investigator.
- •6\) Patients must agree to abstain from alcohol consumption from 24 hours before ONM\-100 administration through end of study (Study Day 17\)
- •7\) Patients should not be taking, nor take concomitantly, any medication that has, in the opinion of the investigator, a substantial risk of hepatotoxicity
Exclusion Criteria
- •1\) Medical or psychiatric conditions that compromise the patient\*s ability to give informed consent.
- •2\) Concurrent uncontrolled medical conditions.
- •3\) Received an investigational drug within 30 days prior to the dose of ONM\-100\.
- •4\) Tumors at sites of which the surgeon would assess that in vivo imaging would not be feasible.
- •5\) Had within 6 months prior to enrolment: myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease (ALT \>3X ULN\* or increased total bilirubin), unstable angina.
- •6\) Received prior to surgery neoadjuvant therapies (chemotherapy, radiation, target therapies) on respective tumor (Only applicable for phase 1a)
- •7\) Inadequately controlled hypertension with or without current antihypertensive medications.
- •8\) History of allergic reaction or infusion reactions to iodine, iodine based contrast or shellfish, indocyanine green (ICG) or any other components of ONM\-100\.
- •9\) Receiving medication with high chance of hepatotoxicity, as judged by the PI based on standard protocols within the UMCG and Dutch database (in Dutch: Farmacotherapeutisch Kompas)
- •10\) Pregnant or lactating women. Documentation of a negative pregnancy test must be available for women of childbearing potential. Moreover, the need to be willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter. Woman of childbearing potential are premenopausal women with intact reproductive organs and women less than two years after menopause.
Outcomes
Primary Outcomes
Not specified
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