Esophageal CancerPhase 1OPTICNCT05450484
Quantitative Fluorescence Endoscopy Using Durvalumab-680LT in Esophageal Cancer
A Phase 1 study testing Fluorescence endoscopy using durvalumab-680LT in people with Esophageal Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Treatment of patients with locally advanced esophageal cancer (EC) is multidisciplinary and consists of neoadjuvant therapy followed by surgical removal of the esophageal tumor and potentially tumor positive lymph nodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Fluorescence endoscopy using durvalumab-680LT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Apr 2023to 1 Dec 2024
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lesion suspected for locally advanced EC (cT1b-4a N0-3 M0)
- Indication for neoadjuvant therapy
- Age ≥ 18 years;
- Written informed consent.
Who cannot join
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent according to treating medical physician;
- Concurrent uncontrolled medical conditions according to treating medical physician;
- Medical history of auto-immune disease
- Pregnancy or breast feeding. A negative pregnancy test must be available for women of childbearing potential (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause);
- Irradical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of the primary tumor prior to start of neoadjuvant therapy according to the patient's medical history;
- Received an investigational drug within 30 days prior to the dose of durvalumab-680LT according to the patient's medical history;
- History of infusion reactions to durvalumab or other monoclonal antibodies according to the patient's medical history;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optical PD-L1 Imaging Using Quantitative Fluorescence Endoscopy in Locally Advanced Esophageal Cancer Using Durvalumab-680LT: a Multicenter Feasibility and Safety Study
Treatment of patients with locally advanced esophageal cancer (EC) is multidisciplinary and consists of neoadjuvant therapy followed by surgical removal of the esophageal tumor and potentially tumor positive lymph nodes. The beneficial effect of the addition of immunotherapy to improve response rates to current treatment strategies has been investigated response to, since only 16 to 43% of EC patients achieve a pathological complete response (pCR) after neoadjuvant therapy and a pCR is associated with better long-term outcomes. Unfortunately, not all patients respond to immunotherapy and the knowledge about biomarkers that predict response to therapy are required. A promising novel parameter is tumor programmed death-ligand 1 (PD-L1) expression, one of the immune checkpoints targeted by cancer immunotherapy. Studies performed in patients with various solid tumors demonstrate improved response to immunotherapy and survival benefit in patients with higher PD-L1 expression. Nonetheless, not all patients with high PD-L1 expression show benefit and some without expression do. Moreover, mostly biopsy-based tests are used to assess PD-L1 status, although these tests are prone to errors, partly due to heterogeneity in tissue expression. Novel methods are needed to gain more insight in the PD-L1 expression in order to better select patients who are likely to benefit from immunotherapy. The investigators hypothesize that quantitative fluorescence endoscopy using the tracer durvalumab-680LT targeting PD-L1 is a promising technique to investigate the heterogeneity of PD-L1 expression.
- Conditions
- Esophageal Cancer
- Being tested
- Fluorescence endoscopy using durvalumab-680LT
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence endoscopy using durvalumab-680LTDrug
Tracer administration: The PD-L1-targeted fluorescent tracer durvalumab-680LT will be administered intravenously 2-4 days prior to the endoscopy at the UMCG. Afterwards, patients will be monitored for half an hour by measurements of vital parameters for potential side-effects, such as infusion-related reactions.
Endoscopy procedure: Patients will undergo two endoscopies, before and after neoadjuvant therapy. First, routine high-definition white-light (HD-WL) inspection is used. Quantification of fluorescence using multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy will be performed both in vivo and ex vivo. Subsequently, fluorescence molecular endoscopy (FME) and endoscopic ultrasound (EUS) will be performed. EUS enables single fiber reflectance/single fiber fluorescence (SFR/SFF) spectroscopy measurements via fine needle aspiration (FNA) to gain insight in the drug distribution throughout the tumor. Additionally, biopsies will be obtained.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab-680LT | Experimental | Not described Receives: Drug: Fluorescence endoscopy using durvalumab-680LT |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) Evaluating the heterogeneity of the PD-L1 tumor expression before and after neoadjuvant therapy using quantitative fluorescence endoscopy using the PD-L1-targeted fluorescent tracer durvalumab-680LT
Quantification of the fluorescent durvalumab-680LT signal, both in vivo and ex vivo, using our spectroscopy device before and after neoadjudant treatment.
Measured: Within 12 months after the study procedures
2) Incidence of (severe) adverse events (SAE/AEs) related to administration of durvalumab-680LT assessed by CTCAE
Safety of durvalumab-680LT administration will be assessed by using Common Terminology Criteria for Adverse Events (CTCAE).
Measured: Up to one week after tracer administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start5 Apr 2023
- Primary completion25 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450484
- Sponsor's protocol ID
- 202000424
- Acronym
- OPTIC
- Status last verified
- Apr 2026
- First submitted
- 13 Jun 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical PD-L1 Imaging Using Quantitative Fluorescence Endoscopy in Locally Advanced Esophageal Cancer Using Durvalumab-680LT: a Multicenter Feasibility and Safety Study
- ClinicalTrials.gov ID
- NCT05450484
- Acronym / sponsor ID
- OPTIC / 202000424
- Conditions
- Esophageal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 8 Jul 2022 (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.
Treatment of patients with locally advanced esophageal cancer (EC) is multidisciplinary and consists of neoadjuvant therapy followed by surgical removal of the esophageal tumor and potentially tumor positive lymph nodes. The beneficial effect of the addition of immunotherapy to improve response rates to current treatment strategies has been investigated response to, since only 16 to 43% of EC patients achieve a pathological complete response (pCR) after neoadjuvant therapy and a pCR is associated with better long-term outcomes. Unfortunately, not all patients respond to immunotherapy and the knowledge about biomarkers that predict response to therapy are required. A promising novel parameter is tumor programmed death-ligand 1 (PD-L1) expression, one of the immune checkpoints targeted by cancer immunotherapy. Studies performed in patients with various solid tumors demonstrate improved response to immunotherapy and survival benefit in patients with higher PD-L1 expression. Nonetheless, not all patients with high PD-L1 expression show benefit and some without expression do. Moreover, mostly biopsy-based tests are used to assess PD-L1 status, although these tests are prone to errors, partly due to heterogeneity in tissue expression. Novel methods are needed to gain more insight in the PD-L1 expression in order to better select patients who are likely to benefit from immunotherapy. The investigators hypothesize that quantitative fluorescence endoscopy using the tracer durvalumab-680LT targeting PD-L1 is a promising technique to investigate the heterogeneity of PD-L1 expression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab-680LT | Experimental | Drug: Fluorescence endoscopy using durvalumab-680LT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Lesion suspected for locally advanced EC (cT1b-4a N0-3 M0)
- Indication for neoadjuvant therapy
- Age ≥ 18 years;
- Written informed consent.
Key exclusion criteria (7 listed)
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent according to treating medical physician;
- Concurrent uncontrolled medical conditions according to treating medical physician;
- Medical history of auto-immune disease
- Pregnancy or breast feeding. A negative pregnancy test must be available for women of childbearing potential (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause);
- Irradical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of the primary tumor prior to start of neoadjuvant therapy according to the patient's medical history;
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 |
|---|---|---|
| Fluorescence endoscopy using durvalumab-680LTTracer administration: The PD-L1-targeted fluorescent tracer durvalumab-680LT will be administered intravenously 2-4 days prior to the endoscopy at the UMCG. Afterwards, patients will be monitored for half an hour by measurements of vital parameters for potential side-effects, such as infusion-related reactions. Endoscopy procedure: Patients will undergo two endoscopies, before and after neoadjuvant therapy. First, routine high-definition white-light (HD-WL) inspection is used. Quantification of fluorescence using multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy will be performed both in vivo and ex vivo. Subsequently, fluorescence molecular endoscopy (FME) and endoscopic ultrasound (EUS) will be performed. EUS enables single fiber reflectance/single fiber fluorescence (SFR/SFF) spectroscopy measurements via fine needle aspiration (FNA) to gain insight in the drug distribution throughout the tumor. Additionally, biopsies will be obtained. | Drug | Durvalumab-680LT |
Primary outcome
1) Evaluating the heterogeneity of the PD-L1 tumor expression before and after neoadjuvant therapy using quantitative fluorescence endoscopy using the PD-L1-targeted fluorescent tracer durvalumab-680LT
Time frame: Within 12 months after the study procedures
Quantification of the fluorescent durvalumab-680LT signal, both in vivo and ex vivo, using our spectroscopy device before and after neoadjudant treatment.
2) Incidence of (severe) adverse events (SAE/AEs) related to administration of durvalumab-680LT assessed by CTCAE
Time frame: Up to one week after tracer administration
Safety of durvalumab-680LT administration will be assessed by using Common Terminology Criteria for Adverse Events (CTCAE).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 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. 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?
A Phase 1 study testing Fluorescence endoscopy using durvalumab-680LT in people with Esophageal Cancer, 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 4 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: finished, as of the sponsor's last update on 13 Apr 2026. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1) Evaluating the heterogeneity of the PD-L1 tumor expression before and after neoadjuvant therapy using quantitative fluorescence endoscopy using the PD-L1-targeted fluorescent tracer durvalumab-680LT (time frame: Within 12 months after the study procedures). The study lists 2 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 13 Apr 2026.