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BRIEF 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

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


  • Org Study ID: ON-1002
  • Secondary ID:
  • NCT ID: NCT03735680
  • NCT Alias:
  • Sponsor: OncoNano Medicine, Inc. - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting August 9, 2019 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Measure mean fluorescence intensity of histologically confirmed tumor vs normal tissue in patients undergoing routine surgery [Tumor to Background Ratio (TBR)]

Primary Outcome 1 - Time Frame: 1 day

Primary Outcome 2 - Measure: Incidence rate of all treatment-emergent adverse events (TEAEs) from time of ONM-100 administration through Day 14

Primary Outcome 2 - Time Frame: 14 days

Condition:

  • Breast Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Colorectal Cancer
  • Bladder Cancer
  • Prostate Cancer
  • Ovarian Cancer

Eligibility

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, 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Yalia Jayalakshmi, PhD

Role: Study Director

Affiliation: OncoNano Medicine, Inc.

Overall Contact

Name: Yalia Jayalakshmi, PhD

Phone: 650-861-0608

Email: jaya@onconanomed.com

Location

Facility Status Contact
The University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Recruiting Herbert Zeh, MD