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Completed

NCT Number: NCT03735680

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

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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma, Transitional Cell Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-small Cell Lung Cancer Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urothelial Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Pennsylvania, Philadelphia, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONM-100

Drug

A polymer micelle covalently conjugated to indocyanine green.

Primary outcomes

  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

    Part 1: Evaluate the dose(s) at which ONM-100 fluorescence imaging is feasible at 3±2 hours post dose.

    Part 2: Verify the safety and diagnostic performance of ONM-100 compared to standard pathology at the dose(s) and imaging schedule(s) post dose selected from Part 1 for the detection of primary tumors and the metastatic lymph nodes in a variety of solid cancers (which could have included HNSCC, breast cancer, colorectal cancer, urothelial cancer, prostate cancer, ovarian cancer, and/or non-small cell lung carcinoma [NSCLC]).

    Part 3: Assess the safety and efficacy (sensitivity and positive predictive value [PPV] of ONM-100 for intraoperative imaging during HNSCC surgery.

  2. Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28

    Time frame: 28 days

    Evaluate safety at the dose(s) used to assess imaging feasibility and select the dose(s) and imaging schedule(s) post dose that are safe and provide optimal imaging of solid tumors and metastatic lymph nodes; the dose and time post dose chosen for the detection of primary tumors and metastatic lymph nodes could be the same or different.

Secondary outcomes

  1. Evaluate Pharmacokinetic Parameters: Cmax

    Time frame: 6 days

    Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging at doses of 1 mg/kg, 2 mg/kg and 3 mg/kg.

  2. Evaluate Pharmacokinetic Parameters: Tmax

    Time frame: 6 days

    Evaluate the time to Cmax (Tmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.

  3. Evaluate Pharmacokinetic Parameters: AUC

    Time frame: 6 days

    Evaluate the Area under the time-concentration curve [AUC] of ONM-100 at 1 mg/kg, 2 mg/kg, and 3 mg/kg doses.

  4. Evaluate Pharmacokinetic Parameters: CL

    Time frame: 6 days

    Evaluate Total body clearance [CL] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.

  5. Evaluate Pharmacokinetic Parameters: Vz

    Time frame: 6 days

    Evaluate the Volume of distribution [Vz] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.

  6. Evaluate Pharmacokinetic Parameters: t1/2

    Time frame: 6 days

    Evaluate the Terminal elimination half-life [t1/2] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.

Sponsors and collaborators

Lead sponsor

OncoNano Medicine, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 8, 2018
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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