A Study of Intravital Microscopy (IVM) in Human Solid Tumors

Overview

Información sobre este estudio

The purpose of this study is to determine the feasibility of performing HIVM in patients with deep space solid tumors during standard course of surgical resection.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • 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.
  • 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 GFR < 45.
  • Liver dysfunction as defined by Child-Pugh score > 5, or LFT's 1.5x 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 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 surgery as the standard of care (e.g. high disease burden where alternative treatments like systemic chemotherapy would be preferred).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/22/23. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Emmanuel Gabriel, M.D., Ph.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos sobre cáncer

Teléfono: 855-776-0015 (toll-free)

Preguntas de estudios clínicos para pacientes internacionales