Solid tumor types Breast cancer Esophageal cancer Colorectal cancer Head and Neck cancer
Conditions
Interventions
- Intravenous injection of ONM-100 approximately 24h prior to surgery. During surgery,
fluorescence imaging will be performed.
Sponsors
OncoNano Medicine Inc., Texas, USA
Eligibility
Inclusion criteria
Inclusion criteria: 1) Biopsy confirmed diagnosis of primary or recurrent respective tumor type and scheduled to undergo surgical 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
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 enrollment: 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, Breast Cancer) 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 and 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. 11) Lab values that in the opinion of the primary surgeon would prevent surgical resection. 12) Magnesium, potassium and calcium lower than the lower limit of normal range. 13) Life expectancy < 12 weeks 14) Karnofsky performance status < 70%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To evaluate safety and pharmacokinetics of a single dose of ONM-100 administered intravenously in patients with solid tumors (HNSCC, Breast Cancer, Colorectal Cancer and Esophageal cancer) - To assess the feasibility of using ONM-100 for intraoperative imaging of solid tumors (HNSCC, Breast Cancer, Colorectal Cancer and Esophageal Cancer). | — |
Secondary
| Measure | Time frame |
|---|---|
| - To determine a range of safe doses of ONM-100 for intra-operative imaging of solid tumors and metastatic nodes with an adequate Tumor to Background Contrast Ratio (CNR). o Breast tumors will be used in phase 1a to determine optimal dose for phase 1b (see section 3, study design) - To evaluate suitability of commonly used camera systems for intra-operative imaging with ONM-100 (Novadaq and/or Surgvision imaging systems) | — |
Contacts
Public ContactG.M. Dam, van
University Medical Center Groningen Department of Surgery / BioOptical Imaging Center Groningen
Outcome results
None listed