NCT03735680 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2023-07-07

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]

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outcome · POSTED

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

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outcome · POSTED

Evaluate Pharmacokinetic Parameters: Cmax

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outcome · POSTED

Evaluate Pharmacokinetic Parameters: Tmax

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outcome · POSTED

Evaluate Pharmacokinetic Parameters: AUC

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outcome · POSTED

Evaluate Pharmacokinetic Parameters: CL

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outcome · POSTED

Evaluate Pharmacokinetic Parameters: Vz

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outcome · POSTED

Evaluate Pharmacokinetic Parameters: t1/2

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.
intervention Names
Drug: ONM-100
label
Patients receiving ONM-100
type
EXPERIMENTAL

interventions

arm Group Labels
Patients receiving ONM-100
description
A polymer micelle covalently conjugated to indocyanine green.
name
ONM-100
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

DIAGNOSTIC

Enrollment

count: 30
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
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
description
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.
measure
Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28
time Frame
28 days

secondary Outcomes

description
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.
measure
Evaluate Pharmacokinetic Parameters: Cmax
time Frame
6 days
description
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.
measure
Evaluate Pharmacokinetic Parameters: Tmax
time Frame
6 days
description
Evaluate the Area under the time-concentration curve \[AUC\] of ONM-100 at 1 mg/kg, 2 mg/kg, and 3 mg/kg doses.
measure
Evaluate Pharmacokinetic Parameters: AUC
time Frame
6 days
description
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.
measure
Evaluate Pharmacokinetic Parameters: CL
time Frame
6 days
description
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.
measure
Evaluate Pharmacokinetic Parameters: Vz
time Frame
6 days
description
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.
measure
Evaluate Pharmacokinetic Parameters: t1/2
time Frame
6 days

Full 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.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
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requested nct id
NCT03735680
primary nct id
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source kind
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Small+Intestine+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
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payload
clinical indication matching status
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id
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nct id
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occurrences
context exact
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end
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exact text
NCT03735680
start
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offset unit
unicode_code_points
query cond
Small Intestine Cancer
query disease state id
ds-small-intestine-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-small-intestine-cancer-000.json
source file sha256
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source json pointer
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source kind
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source record id
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source string basis
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Small+Intestine+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice