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

Sponsor
OncoNano Medicine, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03735680
Collaborator
(none)
30
Enrollment
3
Locations
1
Arm
27.3
Actual Duration (Months)
10
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Aug 9, 2019
Actual Primary Completion Date :
Oct 14, 2021
Actual Study Completion Date :
Nov 18, 2021

Arms and Interventions

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

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)] [1 day]

  2. Incidence rate of all treatment-emergent adverse events (TEAEs) from time of ONM-100 administration through Day 28 [28 days]

Secondary Outcome Measures

  1. Evaluate pharmacokinetic parameters: Cmax [6 days]

    Maximum plasma concentration [Cmax]

  2. Evaluate pharmacokinetic parameters: Tmax [6 days]

    Time to Cmax [Tmax]

  3. Evaluate pharmacokinetic parameters: AUC [6 days]

    Area under the time-concentration curve [AUC]

  4. Evaluate pharmacokinetic parameters: CL [6 days]

    Total body clearance [CL]

  5. Evaluate pharmacokinetic parameters: Vss [6 days]

    Volume of distribution [Vss]

  6. Evaluate pharmacokinetic parameters: t1/2 [6 days]

    Terminal elimination half-life [t1/2]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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, 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

Locations

Site City State Country Postal Code
1 The University of Pennsylvania Philadelphia Pennsylvania United States 19104
2 The University of Texas Southwestern Medical Center Dallas Texas United States 75390
3 The University of Texas - M.D. Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • OncoNano Medicine, Inc.

Investigators

  • Study Director: Trials@OncoNanoMed.com, OncoNano Medicine, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
OncoNano Medicine, Inc.
ClinicalTrials.gov Identifier:
NCT03735680
Other Study ID Numbers:
  • ON-1002
First Posted:
Nov 8, 2018
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
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:
Carcinoma
Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Feb 11, 2022