Investigation of Hemoglobin Oxygenation With Third Harmonic Generation Microscopy

Diabetes Clinical Trial

Official title:

Investigation of Hemoglobin Oxygenation With Third Harmonic Generation Microscopy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03619356
• Other study ID #: 201709032RINB
• Status: Enrolling by invitation
• Start date: February 5, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• older than 20 years old

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Diabetes
• Hypoxia
• Oxygen Deficiency
• Tumor

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observe the extent of tumor growth via morphological information	To observe the extent of tumor growth (with units of mm2) via morphological information. Morphological information are presented as density and shape of red blood cells.	2 years
Primary	Observe the extent of tumor growth via spectral THG intensity distribution	To observe the extent of tumor growth (with units of mm2) via spectral THG distributions. The spectral distributions are presented by the ratio between different channels. And the ratio can be calculated by analyzing the excited fluorescence intensity.	2 years
Primary	Change in spectral THG strength distribution	Obtain THG strength in 3 different channels for chemically treated whole blood samples for oxygenation, deoxygenation and other status. The spectral distributions are presented by the ratio between different channels.	2 years
Secondary	Quantify the extent of diseases in spectral THG strength distribution	With calculating the ratio of THG strength for chemically treated whole blood samples for oxygenation and deoxygenation and other status from different channels, the extent of other diseases can be quantified.	1 year