RightFit
RecruitingNot applicable

Intravital Microscopy in Human Solid Tumors

Intravital Microscopy (IVM) in Human Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses intravital microscopy (IVM) to watch blood vessels inside solid tumors in real time. It is for adults with certain tumors that need surgery. Researchers want to see if the blood vessels work well enough to carry medicine given throughout the body to the tumor.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have an ECOG activity score of 0–2: you can care for yourself and are up and about at least half of your waking hours.
  • Your tumor can be seen and measured directly and needs removal in an operating room.
  • Your cancer started in the stomach, pancreas, liver or bile system, colon or rectum, brain, or breast, or is a sarcoma (cancer of bone or soft tissue). Breast cancer may involve underarm lymph nodes. The tumor may be where it started or have spread.
  • You understand that this is a research study and sign an approved consent form.
  • After signing consent, you have a skin prick test before surgery to check for a reaction to fluorescein, a dye.

Who can't join

  • You have an uncontrolled illness, such as an active infection, heart failure with symptoms, unstable chest pain, an irregular heartbeat, or a mental health or social problem.
  • Your kidneys do not work well enough: your GFR, a measure of kidney filtering, is below 45.
  • Your liver does not work well enough: your Child-Pugh liver score is above 5, or liver blood tests are 1.5 times above the normal range.
  • You have a known allergy, past reaction, or positive skin prick test to fluorescein dye.
  • You are pregnant or breastfeeding. A urine pregnancy test is done before surgery.
  • You are unwilling or unable to follow the study rules.
  • The study doctor thinks a condition makes the study unsuitable for you or requires more tests, such as an abnormal EKG (a test of the heart’s electrical activity).
  • You have a condition that means surgery to remove the tumor is not standard care for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study sites (1)

FL