Clinical trial NCT03619356: Investigation of Hemoglobin Oxygenation With Third Harmonic Generation Microscopy
Official title: Investigation of Hemoglobin Oxygenation With Third Harmonic Generation Microscopy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hypoxia
Oxygen Deficiency
Tumor
Diabetes
Keywords: hemoglobin
oxygenation concentration
tumor
diabetes
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers with any genders with the age older than 20 years.

Brief summary: The specific aims of the project are performing a pre-clinical study on a human model and evaluating the oxygenation and other status of human erythrocytes by spectrally-resolved third harmonic generation (srTHG) microscopy . By analyzing the partitioned third harmonic generation (THG) spectra of oxygenated and deoxygenated erythrocytes ex vivo, the investigators aim to provide a reference standard for quantifying oxygenation and molecular status in this project.

Detailed description: Recently, oximeter, detecting the spectral response at wavelengths of 660nm and 940nm, is widely used to measured oxygenation status. Its low spatial resolution and limited penetration depth in human skin, however, restrict the oximeter in clinical application especially for early detection of cancer. In early-stage cancer development, angiogenesis and oxygen depletion around tumor are two important indicators of tumor growth. If an angiogenesis and low oxygenation status can be identified simultaneously, the investigators can point out the early-stage tumor from normal tissue easily.

The investigators have been working towards the development of third harmonic generation microscopy systems and reported the success of revealing morphology in human skin specimen. Since THG process is based on virtual transition without energy deposition, THG microscopy enables imaging ex vivo specimens without extra label and invasive procedure. To further investigate biological process of biomaterials, the investigators develop a srTHGM where THG spectrum is partitioned to analyze during imaging process. In this project, the investigators aim to elucidate oxygenation concentration and other specific biological molecular of red blood cells through the srTHG microscopy system.

The abilities to reveal structure morphology and its corresponding biological information in situ would provide assistance to diagnose early-stage of tumor and other diseases as well as a potential support in clinical treatment.

Eligibility criteria: Inclusion Criteria:

* older than 20 years old

Exclusion Criteria:

* Vulnerable groups, such as pregnant women, prisoners, students, mentally handicapped, aborigines, etc.

Primary outcomes:
measure: Observe the extent of tumor growth via morphological information
timeFrame: 2 years
measure: Observe the extent of tumor growth via spectral THG intensity distribution
timeFrame: 2 years
measure: Change in spectral THG strength distribution
timeFrame: 2 years
Secondary outcomes:
measure: Quantify the extent of diseases in spectral THG strength distribution
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: