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

  • STATUS
    Recruiting
  • days left to enroll
    79
  • participants needed
    60
  • sponsor
    OncoNano Medicine, Inc.
Updated on 29 January 2021
cancer
carcinoma
breast cancer
squamous cell carcinoma
lung cancer
solid tumour
ovarian cancer
squamous cell carcinoma of head and neck
colorectal neoplasm
cancer of the ovary
lung carcinoma

Summary

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.

Details
Condition Malignant neoplasm of prostate, Non-Small Cell Lung Cancer, Ovarian disorder, Colorectal Cancer, Rectal disorder, Prostatic disorder, Breast Cancer, Ovarian Cancer, Transitional cell carcinoma, Prostate Disorders, Colon Cancer Screening, Prostate Cancer, Early, Recurrent, Rectal Disorders, Colon cancer; rectal cancer, Ovarian Function, Squamous Cell Carcinoma of the Head and Neck, Breast Cancer Diagnosis, Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Recurrent Ovarian Cancer, Prostate Cancer, Urothelial Carcinoma, breast carcinoma, colorectal neoplasm, prostate carcinoma, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, cancer, breast, colorectal cancers, nsclc, ovarian tumors, prostate cancers, cancer, colorectal, colorectal tumor, tumors, colorectal
Treatment ONM-100
Clinical Study IdentifierNCT03735680
SponsorOncoNano Medicine, Inc.
Last Modified on29 January 2021

Eligibility

Yes No Not Sure

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
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