A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer

OncoNano Medicine

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Non-small Cell Lung Cancer; Urothelial Carcinoma; Ovarian Cancer; Prostate Cancer; Colorectal Cancer; Head and Neck Squamous Cell Carcinoma

Treatments: Drug: ONM-100

Study type: Interventional

Funder types: Industry

Identifiers

NCT03735680

ON-1002

Details and patient eligibility

About

This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine surgery.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled to undergo surgical resection
• Part 1: Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or breast cancer
• Part 2: Biopsy-confirmed diagnosis of HNSCC, breast cancer, colorectal cancer, prostate cancer, ovarian cancer, urothelial carcinoma and non-small cell lung cancer.
• Part 3: Stage 2 to 4 HNSCC Including T0 or Tx unknown Primary cancers

Exclusion criteria

• Histologically diagnosed by an excisional biopsy procedure
• Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible
• Life expectancy <12 weeks
• Hepatic impairment (Child-Pugh score >5) or significant liver disease including active hepatitis or cirrhosis

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Patients receiving ONM-100

Experimental group

Description:

All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.

Treatment:

Drug: ONM-100