HypoxiaNCT03619356
Investigation of Hemoglobin Oxygenation With Third Harmonic Generation Microscopy
An observational study of Hypoxia and Oxygen Deficiency, run by National Taiwan University Hospital at 1 site in Taiwan.
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 . Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Oxygen Deficiency, Tumor
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Feb 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers with any genders with the age older than 20 years.
Who may be able to join
- older than 20 years old
Who cannot join
- Vulnerable groups, such as pregnant women, prisoners, students, mentally handicapped, aborigines, etc.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypoxia, Oxygen Deficiency, Tumor, Diabetes
- Keywords
- hemoglobin, oxygenation concentration, tumor, diabetes
- Medical subject headings
- Hypoxia, Neoplasms, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start5 Feb 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619356
- Sponsor's protocol ID
- 201709032RINB
- Status last verified
- Nov 2023
- First submitted
- 11 Jun 2018
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Hemoglobin Oxygenation With Third Harmonic Generation Microscopy
- ClinicalTrials.gov ID
- NCT03619356
- Acronym / sponsor ID
- 201709032RINB
- Conditions
- Hypoxia, Oxygen Deficiency, Tumor, Diabetes
- Keywords
- hemoglobin, oxygenation concentration, tumor, diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers with any genders with the age older than 20 years.
Key inclusion criteria (1 listed)
- older than 20 years old
Key exclusion criteria (1 listed)
- Vulnerable groups, such as pregnant women, prisoners, students, mentally handicapped, aborigines, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Observe the extent of tumor growth via morphological information
Time frame: 2 years
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.
Observe the extent of tumor growth via spectral THG intensity distribution
Time frame: 2 years
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.
Change in spectral THG strength distribution
Time frame: 2 years
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.
1 secondary outcome
Quantify the extent of diseases in spectral THG strength distribution
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia and Oxygen Deficiency, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observe the extent of tumor growth via morphological information (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.