Clinical trial NCT04950166: A Study to Evaluate ONM100, an Intraoperative Fluor Imaging Agent for the Detection of Peri Mets
Official title: A Phase 2, Open-Label Study to Evaluate the Performance and Safety of ONM100, an Intraoperative Fluor Imaging Agent for the Detection of Peritoneal Mets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peritoneal Carcinomatosis
Lead sponsor: OncoNano Medicine, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-06
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A two group interventional, open-label, single arm trial where each patient is his/her own intrapatient control. All patients will receive a single dose of pegsitacianine administered intravenously prior to standard of care surgery.
Primary purpose: DIAGNOSTIC

Brief summary: Peritoneal carcinomatosis (PC) results from the metastasis of a primary cancer of the peritoneum (e.g., appendiceal, ovarian, uterine, colorectal, and gastric cancers) that then disseminates throughout the abdominal cavity. Historically progression to PC was considered terminal and resulted in survival times on the scale of a few months with palliative care being the best option for patients. More recently, cytoreductive surgery (CS) has emerged as a means to prolong and improve patient lives with a median increase in survival of up to \~5 years. It has been reported that for every 10% increase in cytoreduction there is a 5.5% increase in median survival time. In addition to surgical tumor debulking within the peritoneal space, it has also been shown that coupling surgical intervention with hyperthermic intraperitoneal chemotherapy (HIPEC) can have an even greater impact on patient outcomes. Pegsitacianine, a micellar fluorescence agent, exploits the ubiquitous pH differences observed between cancerous and normal tissues. This in turn, provides a highly sensitive and specific fluorescence response after localizing within the tumor microenvironment, thus allowing the detection of primary tumors, their margins, metastatic disease, and tumor-containing lymph nodes.


Eligibility criteria: Inclusion Criteria:

* Imaging and biopsy confirmed metastatic disease of peritoneal origin

Exclusion Criteria:

* Known hypersensitivity or allergy to any component of pegsitacianine
* Tumor locations the surgeon deems unfeasible to image intraoperatively
* Excessive and/or generalized metastatic disease deemed inoperative by the surgeon

Primary outcomes:
measure: Percentage of Patients That Had at Least One Additional Lesion Detected Under Pegsitacianine Guidance Following CRS That Was Confirmed as Positive for Disease by Pathological Evaluation
timeFrame: 1 day
Secondary outcomes:
measure: Sensitivity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen
timeFrame: 7 days
measure: Specificity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen
timeFrame: 7 days
measure: Negative Predictive Value of Pegsitacianine
timeFrame: 7 days
measure: Positive Predictive Value of Pegsitacianine
timeFrame: 7 days
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center / James Cancer Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Perelman School of Medicine, University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: AHN Cancer Institute, West Penn Hospital
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Allegheny Health Network
name: Patrick Wagner, MD
role: PRINCIPAL_INVESTIGATOR
References: