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NCT04950166 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate ONM100, an Intraoperative Fluor Imaging Agent for the Detection of Peri Mets
A Phase 2 study, sponsored by OncoNano Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT04950166 is a Phase 2 study that has completed, run by OncoNano Medicine. The registered enrollment target is 51 participants.
The verdict
NCT04950166, a Phase 2 study, has completed, sponsored by OncoNano Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study 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.
Interventions
- DRUG pegsitacianine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2023-01-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04950166
The ClinicalTrials.gov registry entry for NCT04950166 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OncoNano Medicine, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which pegsitacianine is the first listed.
NCT04950166 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04950166 about?
NCT04950166 is a clinical study titled "A Study to Evaluate ONM100, an Intraoperative Fluor Imaging Agent for the Detection of Peri Mets". 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 survi...
What is the current status of trial NCT04950166?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2021-11-30. Estimated completion is 2023-01-20.
What interventions are being tested in trial NCT04950166?
The interventions under investigation include: pegsitacianine (DRUG).
Who is sponsoring clinical trial NCT04950166?
This trial is sponsored by OncoNano Medicine, which has 4 total clinical trials registered on ClinicalTrials.gov.
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