Brief Title
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure mean fluorescence intensity of histologically confirmed tumor vs normal tissue in patients undergoing routine surgery [Tumor to Background Ratio (TBR)]
Secondary Outcome
Evaluate pharmacokinetic parameters: Cmax
Condition
Breast Cancer
Intervention
ONM-100
Study Arms / Comparison Groups
Patients receiving ONM-100
Description: All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
August 9, 2019
Completion Date
November 18, 2021
Primary Completion Date
October 14, 2021
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, 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
[email protected], ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03735680
Organization ID
ON-1002
Responsible Party
Sponsor
Study Sponsor
OncoNano Medicine, Inc.
Study Sponsor
[email protected], Study Director, OncoNano Medicine, Inc.
Verification Date
February 2022