Human Intravital Microscopy for Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
Mayo Clinic Florida, Jacksonville, FL
Cancer+1 More
Human Intravital Microscopy - Device
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a new technology may help determine if a tumor is more likely to respond to a certain type of treatment.

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Solid Tumors, Adult

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Human Intravital Microscopy will improve 4 primary outcomes and 3 secondary outcomes in patients with Cancer. Measurement will happen over the course of 5-7 days.

12-15 minutes
1. Tumor vessel identification (# tumor vessels visualized per high power field)
2. Tumor vessel density (# tumor vessels per square cm area observed)
3. Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake)
4. Tumor blood flow (velocity, mm/sec)
15-20 minutes
5. Post-operative comparison of the microvasculature of tumor with normal tissue
5 years
Post-operative correlation of the microscopic observation of the tumor microvasculature tumor-specific and overall survival.
5-7 days
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).

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Arm 1

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Human Intravital Microscopy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Arm 1
Device
Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with solid tumors during surgical resection.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5 years for reporting.

Who is running the study

Principal Investigator
E. M. G.
Emmanuel M. Gabriel, Principal Investigator
Mayo Clinic

Closest Location

Mayo Clinic Florida - Jacksonville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.
Age ≥ 18 years of age.
ECOG Performance Status of ≤ 2.
Measurable tumor by direct visualization requiring surgical resection in the OR.
Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, and sarcoma. Tumors may be primary or metastatic to solid or hollow intra-abdominal organs.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common side effects of human intravital microscopy?

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All of the side effects observed in this study will be of similar nature and of similar severity in most patients undergoing human intravital microscopy. It is prudent not to withhold it from any patient on suspicion as a diagnosis of exclusion and most importantly, the patient should be counseled on the risks so that he or she decides not to undergo it for him or herself.

Unverified Answer

Can cancer be cured?

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No conclusive test for carcinoma is known yet. The only treatments for cancer with proven benefit are those that cure the underlying disease. But for many patients with cancer, the treatment for symptoms and the symptom-causing disease can be improved by appropriate medical treatment. At the same time, the psychological wellbeing of patients can be improved by appropriate counselling, and the life quality can be preserved for a prolonged, active and healthy life, and so the chances and chance of dying early and with dignity is improved if the proper treatment is initiated before the occurrence and progression of the cancer.

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How many people get cancer a year in the United States?

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There is an excess of cancer diagnoses in the US, compared to the rate of cancers detected in populations worldwide. The high number of cancer diagnoses is associated with tobacco, diet, and other social exposures, but not other common environmental or biological risk factors.

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What causes cancer?

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Most cancers are a result of an environmental insult, and many such agents act by affecting the genes or their products, in turn affecting the DNA repair or DNA replication cycles. The genetic basis in some cases may include a person's inherited DNA defects in genes such as "p53", which predispose them to cancer, and many other tumour suppressor genes. Exposure to environmental factors such as ultraviolet radiation, cigarette smoking, alcohol consumption, a lack of exposure, poor diets, lack of physical activity and infectious risks such as "H. pylori" are thought to provoke cancer. The link between breast cancer and obesity was firmly established.

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What is cancer?

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This work offers a unique example of how the human brain can integrate information to form cohesive and coherent knowledge about its human and human-relevant environment. Although the brain is responsible for producing this sort of knowledge, and as we shall show here it is only one way that the brain does so, these and other neural representations help us to better understand how our environment shapes our thoughts. Understanding how the brain processes its own 'inner' information and what it does with it will help us better understand the workings of other brain structures, such as the medial temporal lobes that are involved in memory retrieval and consolidation.

Unverified Answer

What are the signs of cancer?

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There are two modes of disease manifestation:  - local - presents like other disease manifestations;  - distant - presents in a different organs/organ systems that causes symptoms, signs, and disease manifestations,\nhowever, the most common way of diagnosing cancer are in doctors' hands;\nhowever, we all have to look out for these signs that might indicate something is wrong\nand even then,  this is not always possible to interpret in a timely manner.

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What are common treatments for cancer?

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Treatment for cancer varies widely among patients and the disease and patient are highly individualized. The common treatment options discussed here may not be applicable globally.

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Does human intravital microscopy improve quality of life for those with cancer?

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This is the first study to objectively measure the quality of life of cancer patients with the use of human intravital microscopy. A small number of patients were studied, and the statistical analyses were not powered for detecting any statistical differences. Findings from a recent study is a step towards developing a standard method of measuring quality of life with the use of human intravital microscopy.

Unverified Answer

Has human intravital microscopy proven to be more effective than a placebo?

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The addition of human intravital microscopy on the treatment of the disease has proven to be more effective than a placebo, and is therefore recommended as standard treatment, along with other methods used in the medical practice. In contrast to recent literature, there was a significant negative influence on the survival of patients treated using human intravital microscopy, when compared with other treatment methods. Findings from a recent study indicate that the intravital microscopy technique should be used with care while confirming the necessity of human intravital microscopy when treating patients with cancer.

Unverified Answer

What is human intravital microscopy?

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HI can provide a diagnostic means in detecting, diagnosing, counting, classifying and classifying prognosis of cancer cells and identifying the distribution type of cancer cells without the requirement of microscope and pathology. The detection and diagnostic effects were high. The most frequent type of cancer cell detected and classified by these methods was of clear-cell lung cancer, followed by ovarian cancer, non-small-cell lung cancer and prostate cancer; the most frequent prognostic and classification effects were obtained in lung cancer, prostate cancer and breast cancer. The advantages of HI as a non-invasive and reproducible method of detecting, diagnosing and classifying cancer cell/cell distribution type, prognosis and classification in a short interval are very considerable.

Unverified Answer

Who should consider clinical trials for cancer?

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Clinicians have a clear need to learn how to assess how likely a patient is to benefit from clinical trials. This should include discussions of both patient and clinician values for the procedure and patient expectations; as well as tools for assessing comorbidities and risk factors for adverse effects of the therapy. Given the limitations of the evidence base and the potential risks, current guidelines should consider the appropriateness of trial participation for most patients and recommend trial participation for only those who are at high risk for disease progression.

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Does cancer run in families?

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There was no evidence that cancer has a hereditary basis, or that any form of cancer has a hereditary predisposition in this population, based on the results of our evaluation of 1328 family relationships.

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