Clinical trial · Interventional
Intravital Microscopy (IVM) in Patients With Peritoneal Carcinomatosis (PC)
NCT03517852CI-TRIAL-00073118completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will investigate the tumor-associated vasculature of patients with peritoneal carcinomatosis, or cancer that spreads along the inner abdominal lining. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the tumor-associated vessels of peritoneal disease. The IVM observations may determine if an individual patient's tumor vessels would be amenable to receiving systemic therapy, based on the functionality of the vessels.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Human Intravital Microscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with peritoneal carcinomatosis during standard course of treatment (cytoreductive surgery with hyperthermic intraperitoneal chemotherapy, or CRS-HIPEC).
- interventionNames
- Device: Human Intravital Microscopy
Primary outcomes (4)
- measure
- Tumor vessel identification (# tumor vessels visualized per high power field)
- timeFrame
- 15-20 minutes
- description
- Identify and measure vessels associated with peritoneal tumor implants
- measure
- Tumor vessel density (# tumor vessels per square cm area observed)
- timeFrame
- 15-20 minutes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years of age. 2. Have an ECOG Performance Status of ≤ 2. Refer to Appendix C. 3. Have measurable disease in the peritoneum by direct visualization (visible lesion typically \> 0.5 cm in maximal diameter). 4. Carcinomatosis that meets indications for CRS-HIPEC. 5. Subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. 6. A negative skin-prick test to fluorescein. Exclusion Criteria: 1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations. 2. Renal dysfunction as defined as a GFR \< 45. 3. Liver dysfunction as defined by Child-Pugh score \> 5, or LFT's 1.5x above normal range. 4. Any known allergy or prior reaction to fluorescein or ICG or a positive skin prick test to fluorescein. 5. Pregnant or nursing female subjects, determined preoperatively with a urine pregnancy test. 6. Unwilling or unable to follow protocol requirements. 7. Any condition which in the Investigators' opinion deems the patient unsuitable (e.g., abnormal EKG). 8. Any condition that excludes CRS-HIPEC as the standard of care for the patient.
References
Publications (22)
- BACKGROUNDFisher DT, Chen Q, Skitzki JJ, Muhitch JB, Zhou L, Appenheimer MM, Vardam TD, Weis EL, Passanese J, Wang WC, Gollnick SO, Dewhirst MW, Rose-John S, Repasky EA, Baumann H, Evans SS. IL-6 trans-signaling licenses mouse and human tumor microvascular gateways for trafficking of cytotoxic T cells. J Clin Invest. 2011 Oct;121(10):3846-59. doi: 10.1172/JCI44952. Epub 2011 Sep 19. PMID 21926464
- BACKGROUNDFisher DT, Muhitch JB, Kim M, Doyen KC, Bogner PN, Evans SS, Skitzki JJ. Intraoperative intravital microscopy permits the study of human tumour vessels. Nat Commun. 2016 Feb 17;7:10684. doi: 10.1038/ncomms10684. PMID 26883450
- BACKGROUNDNagy JA, Chang SH, Shih SC, Dvorak AM, Dvorak HF. Heterogeneity of the tumor vasculature. Semin Thromb Hemost. 2010 Apr;36(3):321-31. doi: 10.1055/s-0030-1253454. Epub 2010 May 20. PMID 20490982
- BACKGROUNDNagy JA, Chang SH, Dvorak AM, Dvorak HF. Why are tumour blood vessels abnormal and why is it important to know? Br J Cancer. 2009 Mar 24;100(6):865-9. doi: 10.1038/sj.bjc.6604929. Epub 2009 Feb 24. PMID 19240721
- BACKGROUNDAbdollahi A, Folkman J. Evading tumor evasion: current concepts and perspectives of anti-angiogenic cancer therapy. Drug Resist Updat. 2010 Feb-Apr;13(1-2):16-28. doi: 10.1016/j.drup.2009.12.001. Epub 2010 Jan 12. PMID 20061178
- BACKGROUNDFukumura D, Duda DG, Munn LL, Jain RK. Tumor microvasculature and microenvironment: novel insights through intravital imaging in pre-clinical models. Microcirculation. 2010 Apr;17(3):206-25. doi: 10.1111/j.1549-8719.2010.00029.x. PMID 20374484
- BACKGROUNDSkitzki JJ, Chen Q, Wang WC, Evans SS. Primary immune surveillance: some like it hot. J Mol Med (Berl). 2007 Dec;85(12):1361-7. doi: 10.1007/s00109-007-0245-7. Epub 2007 Aug 18.