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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03735680
Recruitment Status : Completed
First Posted : November 8, 2018
Last Update Posted : February 11, 2022
Sponsor:
Information provided by (Responsible Party):
OncoNano Medicine, Inc.

Study Description
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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 Prostate Cancer Ovarian Cancer Urothelial Carcinoma Non-small Cell Lung Cancer Drug: ONM-100 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
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 & 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
Actual Study Start Date : August 9, 2019
Actual Primary Completion Date : October 14, 2021
Actual Study Completion Date : November 18, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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 28 [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Evaluate pharmacokinetic parameters: Cmax [ Time Frame: 6 days ]
    Maximum plasma concentration [Cmax]

  2. Evaluate pharmacokinetic parameters: Tmax [ Time Frame: 6 days ]
    Time to Cmax [Tmax]

  3. Evaluate pharmacokinetic parameters: AUC [ Time Frame: 6 days ]
    Area under the time-concentration curve [AUC]

  4. Evaluate pharmacokinetic parameters: CL [ Time Frame: 6 days ]
    Total body clearance [CL]

  5. Evaluate pharmacokinetic parameters: Vss [ Time Frame: 6 days ]
    Volume of distribution [Vss]

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


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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03735680


Locations
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United States, Pennsylvania
The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
The University of Texas - M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
OncoNano Medicine, Inc.
Investigators
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Study Director: Trials@OncoNanoMed.com OncoNano Medicine, Inc.
More Information
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Responsible Party: OncoNano Medicine, Inc.
ClinicalTrials.gov Identifier: NCT03735680    
Other Study ID Numbers: ON-1002
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms by Site
Carcinoma, Squamous Cell
Head and Neck Neoplasms