Clinical trial NCT03735680: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Head and Neck Squamous Cell Carcinoma
Colorectal Cancer
Prostate Cancer
Ovarian Cancer
Urothelial Carcinoma
Non-small Cell Lung Cancer
Lead sponsor: OncoNano Medicine, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]
timeFrame: 1 day
measure: Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28
timeFrame: 28 days
Secondary outcomes:
measure: Evaluate Pharmacokinetic Parameters: Cmax
timeFrame: 6 days
measure: Evaluate Pharmacokinetic Parameters: Tmax
timeFrame: 6 days
measure: Evaluate Pharmacokinetic Parameters: AUC
timeFrame: 6 days
measure: Evaluate Pharmacokinetic Parameters: CL
timeFrame: 6 days
measure: Evaluate Pharmacokinetic Parameters: Vz
timeFrame: 6 days
measure: Evaluate Pharmacokinetic Parameters: t1/2
timeFrame: 6 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas - M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: OncoNano Medicine, Inc.
name: Trials@OncoNanoMed.com
role: STUDY_DIRECTOR
References: