Image guided surgery for tumor detection in solid cancers using the pH activated micellar probe ONM-100: The SHINe study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 33

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.
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%.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To evaluate safety and pharmacokinetics of a single dose of ONM-100<br /><br>administered intravenously in patients with solid tumors (HNSCC, breast cancer,<br /><br>rectal cancer and esophageal cancer)<br /><br>- To assess the feasibility of using ONM-100 for intra operative imaging of<br /><br>solid tumors (HNSCC, breast cancer, rectal cancer and esophageal cancer). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To determine a range of safe doses of ONM-100 for intra-operative imaging of<br /><br>solid tumors and metastatic nodes with an adequate Tumor to Background contrast<br /><br>(CNR).<br /><br>- To evaluate usability of commonly used camera systems for intra-operative<br /><br>imaging with ONM-100 (SurgVision and Novadaq imaging systems (see section 7.1))</p><br>