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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03735680
Recruitment Status : Not yet recruiting
First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Information provided by (Responsible Party):
OncoNano Medicine, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Head and Neck Squamous Cell Carcinoma Colorectal Cancer Bladder Cancer Prostate Cancer Ovarian Cancer Drug: ONM-100 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance, Safety, and Timing of Postdose Imaging of ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Solid Tumors Undergoing Routine Surgery
Estimated Study Start Date : February 28, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 31, 2019

Arm Intervention/treatment
Experimental: Patients receiving ONM-100
All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.
Drug: ONM-100
A polymer micelle covalently conjugated to indocyanine green, an FDA-approved fluorophore

Primary Outcome Measures :
  1. Measure mean fluorescence intensity of histologically confirmed tumor vs normal tissue in patients undergoing routine surgery [Tumor to Background Ratio (TBR)] [ Time Frame: 1 day ]
  2. Incidence rate of all treatment-emergent adverse events (TEAEs) from time of ONM-100 administration through Day 14 [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Evaluate pharmacokinetic parameters: Cmax [ Time Frame: 9 days ]
    Maximum plasma concentration [Cmax]

  2. Evaluate pharmacokinetic parameters: Tmax [ Time Frame: 9 days ]
    Time to Cmax [Tmax]

  3. Evaluate pharmacokinetic parameters: AUC [ Time Frame: 9 days ]
    Area under the time-concentration curve [AUC]

  4. Evaluate pharmacokinetic parameters: CL [ Time Frame: 9 days ]
    Total body clearance [CL]

  5. Evaluate pharmacokinetic parameters: Vss [ Time Frame: 9 days ]
    Volume of distribution [Vss]

  6. Evaluate pharmacokinetic parameters: t1/2 [ Time Frame: 9 days ]
    Terminal elimination half-life [t1/2]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, bladder cancer, and ovarian cancer

Exclusion Criteria:

  • Histologically diagnosed by an open biopsy procedure
  • Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible
  • Life expectancy <12 weeks
  • Significant liver disease including active hepatitis, cirrhosis, or alanine aminotransferase or bilirubin above upper limit of normal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03735680

Contact: Yalia Jayalakshmi, PhD 650-861-0608

Sponsors and Collaborators
OncoNano Medicine, Inc.
Study Director: Yalia Jayalakshmi, PhD OncoNano Medicine, Inc.

Responsible Party: OncoNano Medicine, Inc. Identifier: NCT03735680     History of Changes
Other Study ID Numbers: ON-1002
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Carcinoma, Squamous Cell
Urinary Bladder Neoplasms
Head and Neck Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases