Esophageal CarcinomaPhase 1/2BRIGHTNCT07108855
Detection of Upper Gastrointestinal Tumour Depth and Demarcation Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection
A Phase 1/2 study testing Indocyanine Green (IC-Green) and Fluorescence guided identification using indocyanine green in people with Esophageal Carcinoma and Gastric Carcinoma, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Endoscopic submucosal dissection (ESD) is a relatively new technique to treat superficial cancers in the upper gastrointestinal (GI) tract. Previous studies reported high en bloc resection rates (95%-97%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Carcinoma, Gastric Carcinoma
- What is being tested?
- Indocyanine Green (IC-Green) and Fluorescence guided identification using indocyanine green
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2025to 1 Aug 2027
- Phase
- Phase 1/2
- 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
- Patients with confirmed superficial esophageal and/or gastric adenocarcinoma (T1) and are scheduled for ESD within the UMCG;
- Age of 18 years or older;
- Able to provide written informed consent.
- Exclusion Criteria (contraindications for indocyanine green):
- Known allergy to indocyanine green;
- Known allergies to iodine, shellfish and/or clams;
Show all 10Show fewer
- eGFR < 30 mL/min/1.73 m2;
- Pregnancy or breastfeeding;
- Hyperthyroidism.
- Severe liver disease (ascites and cirrhosis).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Centre Groningen
Groningen, Provincie Groningen, 9713GZ
Wouter B. Nagengast, MD, PharmD, PhD, +31(0)503612620, w.b.nagengast@umcg.nl
About this study
Official title: Detection of Upper Gastrointestinal Tumour Depth and Demarcation by Quantified Fluorescence Molecular Endoscopy Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection
Endoscopic submucosal dissection (ESD) is a relatively new technique to treat superficial cancers in the upper gastrointestinal (GI) tract. Previous studies reported high en bloc resection rates (95%-97%). However, R0 resection rates (84.5%) suggest that the tumour is not radically removed in all cases, resulting in a risk of tumour recurrence. One of the key challenges is the limited accuracy in determining the depth of cancer invasion. To reduce the risk of tumour recurrence, the endoscopist would greatly benefit from proper and complete visualization of the tumour margin and depth during ESD. Several studies have shown that near-infrared quantified fluorescence molecular endoscopy (qFME) could serve as a red flag detection method and might be a useful imaging tool for tumour demarcation in the upper GI tract. The aim of this study is to evaluate the feasibility of ICG-enhanced near-infrared qFME to determine tumour demarcation and tumour depth in upper GI tumours (e.g. superficial esophageal and/or gastric adenocarcinoma (T1)) during ESD.
- Conditions
- Esophageal Carcinoma, Gastric Carcinoma
- Being tested
- Indocyanine Green (IC-Green), Fluorescence guided identification using indocyanine green
- Keywords
- Indocyanine Green (ICG), Fluorescence Molecular Endoscopy
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green (IC-Green)Drug
Systemic administration of indocyanine green during the endoscopic procedure.
Fluorescence guided identification using indocyanine greenDiagnostic test
Near-infrared quantified fluorescence molecular endoscopy (qFME) will be used during the endoscopic procedure.
| Study group | Role | What they receive |
|---|---|---|
| Systemic administration of ICG | Experimental | Indocyanine Green (ICG) will be administered systemically 30 minutes before endoscopic submucosal dissection (ESD). Near-infrared quantified fluorescence molecular endoscopy (qFME) will be performed during the procedure. Receives: Drug: Indocyanine Green (IC-Green); Diagnostic Test: Fluorescence guided identification using indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD
Feasibility will be assessed by analyzing the fluorescent imaging data obtained during and after the procedure. Visible fluorescence will be determined by calculating the target-to-background ratio (TBR), where the target is defined as the mean pixel intensity of the resection bed in areas displaying fluorescence.
Measured: One week after the qFME procedure
Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD
Secondary evaluation will focus on whether visible fluorescence after resection correlates with an R1 resection grade based on histopathology.
Measured: One week after the qFME procedure
Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD
Fluorescence will also be quantified using mucosal multi-diameter single-fiber reflectance / single-fiber fluorescence (MDSFR/SFF) spectroscopy, a non-invasive measurement technique.
Measured: After study completion, to be expected within 8 months
Secondary outcomes (1)
Visibility of the papilla of Vater and the intraduodenal part of the extrahepatic biliary anatomy by detecting fluorescent signal with ICG-enhanced qFME
Visibility is determined visual evaluation during the endoscopic procedure and calculating the TBR in the same manner as explained above.
Measured: One week after the qFME procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CarcinomaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108855
- Sponsor's protocol ID
- METc 2025/002
- Other IDs
- NL88635.042.24
- Acronym
- BRIGHT
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Upper Gastrointestinal Tumour Depth and Demarcation by Quantified Fluorescence Molecular Endoscopy Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection
- ClinicalTrials.gov ID
- NCT07108855
- Acronym / sponsor ID
- BRIGHT / METc 2025/002
- Conditions
- Esophageal Carcinoma, Gastric Carcinoma
- Keywords
- Indocyanine Green (ICG), Fluorescence Molecular Endoscopy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 7 Aug 2025 (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.
Endoscopic submucosal dissection (ESD) is a relatively new technique to treat superficial cancers in the upper gastrointestinal (GI) tract. Previous studies reported high en bloc resection rates (95%-97%). However, R0 resection rates (84.5%) suggest that the tumour is not radically removed in all cases, resulting in a risk of tumour recurrence. One of the key challenges is the limited accuracy in determining the depth of cancer invasion. To reduce the risk of tumour recurrence, the endoscopist would greatly benefit from proper and complete visualization of the tumour margin and depth during ESD. Several studies have shown that near-infrared quantified fluorescence molecular endoscopy (qFME) could serve as a red flag detection method and might be a useful imaging tool for tumour demarcation in the upper GI tract. The aim of this study is to evaluate the feasibility of ICG-enhanced near-infrared qFME to determine tumour demarcation and tumour depth in upper GI tumours (e.g. superficial esophageal and/or gastric adenocarcinoma (T1)) during ESD.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic administration of ICG | Experimental | Drug: Indocyanine Green (IC-Green), Diagnostic Test: Fluorescence guided identification using indocyanine greenIndocyanine Green (ICG) will be administered systemically 30 minutes before endoscopic submucosal dissection (ESD). Near-infrared quantified fluorescence molecular endoscopy (qFME) will be performed during the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with confirmed superficial esophageal and/or gastric adenocarcinoma (T1) and are scheduled for ESD within the UMCG;
- Age of 18 years or older;
- Able to provide written informed consent.
- Known allergy to indocyanine green;
- Known allergies to iodine, shellfish and/or clams;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Indocyanine Green (IC-Green)Systemic administration of indocyanine green during the endoscopic procedure. | Drug | Systemic administration of ICG |
| Fluorescence guided identification using indocyanine greenNear-infrared quantified fluorescence molecular endoscopy (qFME) will be used during the endoscopic procedure. | Diagnostic test | Systemic administration of ICG |
Primary outcome
Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD
Time frame: One week after the qFME procedure
Feasibility will be assessed by analyzing the fluorescent imaging data obtained during and after the procedure. Visible fluorescence will be determined by calculating the target-to-background ratio (TBR), where the target is defined as the mean pixel intensity of the resection bed in areas displaying fluorescence.
Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD
Time frame: One week after the qFME procedure
Secondary evaluation will focus on whether visible fluorescence after resection correlates with an R1 resection grade based on histopathology.
Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD
Time frame: After study completion, to be expected within 8 months
Fluorescence will also be quantified using mucosal multi-diameter single-fiber reflectance / single-fiber fluorescence (MDSFR/SFF) spectroscopy, a non-invasive measurement technique.
1 secondary outcome
Visibility of the papilla of Vater and the intraduodenal part of the extrahepatic biliary anatomy by detecting fluorescent signal with ICG-enhanced qFME
Time frame: One week after the qFME procedure
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 7 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Indocyanine Green (IC-Green) and Fluorescence guided identification using indocyanine green in people with Esophageal Carcinoma and Gastric Carcinoma, run by University Medical Center Groningen at 1 site in Netherlands.
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 10 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. 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 Netherlands. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Wouter B. Nagengast, MD, PharmD, PhD (+31(0)503612620, w.b.nagengast@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of ICG-enhanced qFME to determine tumour demarcation and depth in upper gastrointestinal tumours during ESD (time frame: One week after the qFME procedure). 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 7 Aug 2025.