Colorectal CancerPhase 4NCT07861815
Assessing the Feasibility of Using Methylene Blue in Identifying Ureters During Colorectal Surgery
A Phase 4 study testing Intravenous Methylene Blue and Methylene Blue Fluorescence Imaging System in people with Colorectal Cancer and Colorectal Surgery, run by Chinese University of Hong Kong.
Trial summary
This study will assess whether methylene blue fluorescence imaging can help surgeons identify the ureters during colorectal surgery. Methylene blue, given through a vein during the operation, is taken up and excreted by the kidneys, allowing the ureters to appear under a special fluorescence camera system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Surgery, Ureteric Injury
- What is being tested?
- Intravenous Methylene Blue and Methylene Blue Fluorescence Imaging System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years
- Scheduled to undergo open, laparoscopic or robotic colorectal surgery, including right colectomy, extended right colectomy, left colectomy, high anterior resection, low anterior resection, abdominoperineal resection, subtotal colectomy and total colectomy.
Who cannot join
- Unable to understand the aims and objectives of this study and unable to give consent for participation
- Known allergy to methylene blue
- Pregnant
- Taking selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or tricyclic antidepressants (risk of serotonin syndrome)
- Significant renal or hepatic impairment
- Presence of renal or ureteric obstruction
- History of G6PD deficiency (risk of hemolytic anemia)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study will assess whether methylene blue fluorescence imaging can help surgeons identify the ureters during colorectal surgery. Methylene blue, given through a vein during the operation, is taken up and excreted by the kidneys, allowing the ureters to appear under a special fluorescence camera system.
The study will include adults undergoing open, laparoscopic, or robotic colorectal surgery at Prince of Wales Hospital. The surgeons will compare ureter visibility using standard white light with visibility using fluorescence imaging at different stages of the operation. The study will also assess the best dose of methylene blue, the additional time required, the ease of using the imaging system, and whether the imaging findings affect the surgical plan.
The study's hypothesis is that methylene blue fluorescence imaging will make it easier or faster to identify the ureters than white light alone. The technique will be considered feasible if it is helpful in at least 20% of operations-for example, by identifying a ureter earlier or identifying it when it cannot be seen under white light. The findings will help determine whether a larger future study should be conducted.
- Conditions
- Colorectal Cancer, Colorectal Surgery, Ureteric Injury
- Being tested
- Intravenous Methylene Blue, Methylene Blue Fluorescence Imaging System
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Methylene BlueDrug
Intravenous Methylene Blue
Methylene Blue Fluorescence Imaging SystemDevice
Methylene Blue Fluorescence Imaging with Custom Optical Filter (Stryker 1688)
| Study group | Role | What they receive |
|---|---|---|
| Methylene Blue Fluorescence Imaging Arm | Experimental | Intravenous Methylene Blue with Fluorescence Imaging for Ureter Identification Receives: Drug: Intravenous Methylene Blue; Device: Methylene Blue Fluorescence Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cases in which fluorescence imaging with methylene blue is deemed helpful for identifying the index ureter
Measured: Intraoperative - at three predefined stages of the index operation (before dissection, before division of critical structures, and after specimen removal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trevor Yeung, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861815
- Sponsor's protocol ID
- Ureter MB Feasibility
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of Using Methylene Blue in Identifying Ureters During Colorectal Surgery
- ClinicalTrials.gov ID
- NCT07861815
- Acronym / sponsor ID
- Ureter MB Feasibility
- Conditions
- Colorectal Cancer, Colorectal Surgery, Ureteric Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 6 Oct 2026 (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.
This study will assess whether methylene blue fluorescence imaging can help surgeons identify the ureters during colorectal surgery. Methylene blue, given through a vein during the operation, is taken up and excreted by the kidneys, allowing the ureters to appear under a special fluorescence camera system.
The study will include adults undergoing open, laparoscopic, or robotic colorectal surgery at Prince of Wales Hospital. The surgeons will compare ureter visibility using standard white light with visibility using fluorescence imaging at different stages of the operation. The study will also assess the best dose of methylene blue, the additional time required, the ease of using the imaging system, and whether the imaging findings affect the surgical plan.
The study's hypothesis is that methylene blue fluorescence imaging will make it easier or faster to identify the ureters than white light alone. The technique will be considered feasible if it is helpful in at least 20% of operations-for example, by identifying a ureter earlier or identifying it when it cannot be seen under white light. The findings will help determine whether a larger future study should be conducted.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylene Blue Fluorescence Imaging Arm | Experimental | Drug: Intravenous Methylene Blue, Device: Methylene Blue Fluorescence Imaging SystemIntravenous Methylene Blue with Fluorescence Imaging for Ureter Identification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged ≥18 years
- Scheduled to undergo open, laparoscopic or robotic colorectal surgery, including right colectomy, extended right colectomy, left colectomy, high anterior resection, low anterior resection, abdominoperineal resection, subtotal colectomy and total colectomy.
Key exclusion criteria (7 listed)
- Unable to understand the aims and objectives of this study and unable to give consent for participation
- Known allergy to methylene blue
- Pregnant
- Taking selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or tricyclic antidepressants (risk of serotonin syndrome)
- Significant renal or hepatic impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous Methylene BlueIntravenous Methylene Blue | Drug | Methylene Blue Fluorescence Imaging Arm |
| Methylene Blue Fluorescence Imaging SystemMethylene Blue Fluorescence Imaging with Custom Optical Filter (Stryker 1688) | Device | Methylene Blue Fluorescence Imaging Arm |
Primary outcome
Proportion of cases in which fluorescence imaging with methylene blue is deemed helpful for identifying the index ureter
Time frame: Intraoperative - at three predefined stages of the index operation (before dissection, before division of critical structures, and after specimen removal)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Methylene Blue and Methylene Blue Fluorescence Imaging System in people with Colorectal Cancer and Colorectal Surgery, run by Chinese University of Hong Kong.
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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trevor Yeung, MA MBBChir DPhil FRCS (+852 3505 1495, uretertrial@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cases in which fluorescence imaging with methylene blue is deemed helpful for identifying the index ureter (time frame: Intraoperative - at three predefined stages of the index operation (before dissection, before division of critical structures, and after specimen removal)). 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 6 Oct 2026.