Solid Tumor, AdultNCT03823144
Intravital Microscopy in Human Solid Tumors
A study testing Diagnostic Microscopy and Fluorescein Sodium Injection in people with Solid Tumor, Adult and Clinical Stage IV Gastric Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
Trial summary
This study will investigate the tumor-associated vasculature of patients with solid tumors. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the vessels associated with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Clinical Stage IV Gastric Cancer AJCC v8, Malignant Solid Neoplasm
- What is being tested?
- Diagnostic Microscopy and Fluorescein Sodium Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2019to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG)Performance Status of ≤ 2
- Measurable tumor by direct visualization requiring surgical resection in the operating room (OR)
- Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, sarcoma, brain, or breast cancer that may involve the axillary lymph nodes cancers. Tumors may be primary or metastatic
- Subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent
- Subject must have a skin prick test pre-operatively (at the time of the preoperative visit and after signed informed consent for entry into this clinical trial is given) to determine any sensitivity to fluorescein
Who cannot join
- 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
- Renal dysfunction as defined as a glomerular filtration rate (GFR) < 45
- Liver dysfunction as defined by Child-Pugh score > 5, or liver function test (LFT)'s 1.5 x above normal range
- Any known allergy or prior reaction to fluorescein or a positive skin prick test to fluorescein
- Pregnant or nursing female subjects, determined preoperatively with a urine pregnancy test
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigators' opinion deems the patient unsuitable (e.g., abnormal electrocardiography [EKG], including T wave inversion, elevated T waves, prolonged QRS interval, or conduction blocks) or that requires further work-up (including cardiac echo or stress test)
- Any condition that excludes surgical resection as the standard of care for the patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Emmanuel M Gabriel, M.D., Ph. D., 904-953-2523, gabriel.emmanuel@mayo.edu
Emmanuel M Gabriel, M.D., Ph. D.
About this study
Official title: Intravital Microscopy (IVM) in Human Solid Tumors
This study will investigate the tumor-associated vasculature of patients with solid tumors. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the vessels associated with solid tumors. 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of performing human intravital microscopy (HIVM) in patients with deep space solid tumors during standard course of surgical resection.
SECONDARY OBJECTIVES:
- Compare the microscopic observation of the tumor-associated vessels with normal tissue (e.g. peritoneal surface or normal brain tissue) in each individual subject.
II. Correlate the microscopic observations of the tumor-associated vessels with pathologic grade of tumor.
III. To correlate the microscopic observation of the microvasculature with tumor-specific and overall survival.
OUTLINE:
Patients receive fluorescein intravenously (IV) and undergo HIVM over 1-2 minutes per field.
After completion of study, patients are followed up at 2-3 weeks after surgery.
- Conditions
- Solid Tumor, Adult, Clinical Stage IV Gastric Cancer AJCC v8, Malignant Solid Neoplasm, Metastatic Colorectal Carcinoma, Metastatic Gastric Carcinoma, Metastatic Primary Malignant Brain Neoplasm
- Being tested
- Diagnostic Microscopy, Fluorescein Sodium Injection
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Sarcoma, Cholangiocarcinoma, Brain Neoplasms, Breast Neoplasms, Carcinoma, Hepatocellular, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic MicroscopyDevice
Also called Human Intravital Microscopy, IVM, HIVM
Undergo Intravital microscopy (IVM), which allows real-time, direct visualization of microscopic blood vessels and calculation of blood flow.
Fluorescein Sodium InjectionDrug
Also called AK-Fluor, Fluorescite
Given IV as part of IVM procedure
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with solid tumors during surgical resection. Receives: Device: Diagnostic Microscopy; Drug: Fluorescein Sodium Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Tumor vessel identification (# tumor vessels visualized per high power field)
Identify and measure vessels associated with solid tumors
Measured: 12-15 minutes
2. Tumor vessel density (# tumor vessels per square cm area observed)
Determine vessel density per 10x field
Measured: 12-15 minutes
3. Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake)
Visualize vital dye within the vessels (fluorescein)
Measured: 12-15 minutes
4. Tumor blood flow (velocity, mm/sec)
Calculate the blood flow velocity of the vessels and tissue penetration of fluorescent dye as a marker of vessel permeability.
Measured: 12-15 minutes
Secondary outcomes (3)
5. Post-operative comparison of the microvasculature of tumor with normal tissue
Post-operative comparison of the microvasculature of tumor with normal tissue (e.g. peritoneum) in each individual subject using vessel diameters, vessel density, detection of intravital dye and flow rates.
Measured: 15-20 minutes
6. Post-operative correlation of the microvasculature with pathologic features of the tumor implants (i.e. tumor grade) at the time of the final pathology report (5-7 days after surgery).
The investigators will determine if there is a correlation between the microvasculature with pathologic features of the tumor implants (i.e. tumor grade) at the time of the final pathology report (5-7 days after surgery).
Measured: 5-7 days
Post-operative correlation of the microscopic observation of the tumor microvasculature tumor-specific and overall survival.
The investigators will determine if there is a correlation between the microscopic observation of the tumor microvasculature tumor-specific and overall survival.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start28 Feb 2019
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel M Gabriel, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823144
- Sponsor's protocol ID
- 18-010370
- Other IDs
- NCI-2021-02676
- Status last verified
- May 2026
- First submitted
- 28 Jan 2019
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Fisher 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.
PubMed 21926464Fisher 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.
PubMed 26883450Nagy 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.
PubMed 20490982Abdollahi 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.
PubMed 20061178Fukumura 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.
PubMed 20374484Skitzki 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.
PubMed 17704903Jain RK, Munn LL, Fukumura D. Dissecting tumour pathophysiology using intravital microscopy. Nat Rev Cancer. 2002 Apr;2(4):266-76. doi: 10.1038/nrc778.
PubMed 12001988Murooka TT, Mempel TR. Multiphoton intravital microscopy to study lymphocyte motility in lymph nodes. Methods Mol Biol. 2012;757:247-57. doi: 10.1007/978-1-61779-166-6_16.
PubMed 21909917Entenberg D, Kedrin D, Wyckoff J, Sahai E, Condeelis J, Segall JE. Imaging tumor cell movement in vivo. Curr Protoc Cell Biol. 2013 Mar;Chapter 19:19.7.1-19.7.19. doi: 10.1002/0471143030.cb1907s58.
PubMed 23456602McLaughlin RA, Scolaro L, Robbins P, Hamza S, Saunders C, Sampson DD. Imaging of human lymph nodes using optical coherence tomography: potential for staging cancer. Cancer Res. 2010 Apr 1;70(7):2579-84. doi: 10.1158/0008-5472.CAN-09-4062. Epub 2010 Mar 16.
PubMed 20233873Patsialou A, Bravo-Cordero JJ, Wang Y, Entenberg D, Liu H, Clarke M, Condeelis JS. Intravital multiphoton imaging reveals multicellular streaming as a crucial component of in vivo cell migration in human breast tumors. Intravital. 2013 Apr 1;2(2):e25294. doi: 10.4161/intv.25294.
PubMed 25013744Franko J, Shi Q, Goldman CD, Pockaj BA, Nelson GD, Goldberg RM, Pitot HC, Grothey A, Alberts SR, Sargent DJ. Treatment of colorectal peritoneal carcinomatosis with systemic chemotherapy: a pooled analysis of north central cancer treatment group phase III trials N9741 and N9841. J Clin Oncol. 2012 Jan 20;30(3):263-7. doi: 10.1200/JCO.2011.37.1039. Epub 2011 Dec 12.
PubMed 22162570Glehen O, Gilly FN, Boutitie F, Bereder JM, Quenet F, Sideris L, Mansvelt B, Lorimier G, Msika S, Elias D; French Surgical Association. Toward curative treatment of peritoneal carcinomatosis from nonovarian origin by cytoreductive surgery combined with perioperative intraperitoneal chemotherapy: a multi-institutional study of 1,290 patients. Cancer. 2010 Dec 15;116(24):5608-18. doi: 10.1002/cncr.25356. Epub 2010 Aug 24.
PubMed 20737573Elias D, Gilly F, Boutitie F, Quenet F, Bereder JM, Mansvelt B, Lorimier G, Dube P, Glehen O. Peritoneal colorectal carcinomatosis treated with surgery and perioperative intraperitoneal chemotherapy: retrospective analysis of 523 patients from a multicentric French study. J Clin Oncol. 2010 Jan 1;28(1):63-8. doi: 10.1200/JCO.2009.23.9285. Epub 2009 Nov 16.
PubMed 19917863Glehen O, Gilly FN, Arvieux C, Cotte E, Boutitie F, Mansvelt B, Bereder JM, Lorimier G, Quenet F, Elias D; Association Francaise de Chirurgie. Peritoneal carcinomatosis from gastric cancer: a multi-institutional study of 159 patients treated by cytoreductive surgery combined with perioperative intraperitoneal chemotherapy. Ann Surg Oncol. 2010 Sep;17(9):2370-7. doi: 10.1245/s10434-010-1039-7. Epub 2010 Mar 25.
PubMed 20336386