Esophageal CancerPhase 1VICENCT02129933
VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions
A Phase 1 study testing Bevacizumab-IRDye800CW and Near infrared fluorescence endoscopy platform in people with Esophageal Cancer and Dysplasia, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there is a need for better endoscopic visualization and the ability for targeted biopsies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Dysplasia
- What is being tested?
- Bevacizumab-IRDye800CW and Near infrared fluorescence endoscopy platform
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2014to Nov 2016
- 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
- Identified HGD or intramucosal EAC (T1) and therefore candidate for endoscopic mucosal resection therapy
- Mentally competent person, 18 years or older.
- Written informed consent.
- Adequate potential for follow-up.
Who cannot join
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- Submucosal and invasive EAC; EAC with tumor-classification other than T1.
- Concurrent (uncontrolled) medical conditions which disqualify for an endoscopic mucosal resection procedure.
- Previously performed therapeutic endoscopic procedures.
- Pregnancy or breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Intervention Study for the Use of VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions
To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there is a need for better endoscopic visualization and the ability for targeted biopsies. Optical molecular imaging of neoplasia associated biomarkers could form a promising technique to accommodate this need. It is known that the biomarker Vascular Endothelial Growth Factor (VEGF) is overexpressed in dysplastic and neoplastic areas in BE segments versus normal tissue and has proven to be a valid target for molecular imaging. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye IRDye800CW. We hypothesize that when bevacizumab-IRDye800CW is administered, it accumulates in VEGF expressing high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC), enabling early cancer visualization using a newly developed fluorescent NIR fiber-bundle. This hypothesis will be tested in this pilot intervention study.
- Conditions
- Esophageal Cancer, Dysplasia
- Being tested
- Bevacizumab-IRDye800CW, Near infrared fluorescence endoscopy platform
- Keywords
- EAC, HGD, Esophagus
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab-IRDye800CWDrug
Also called Beva-800CW, Bevacizumab-800CW, Avastin-800CW (Roche)
Intravenous administration of a microdose (4.5mg, subtherapeutic) of Bevacizumab-IRDye800CW 2 days prior to the fluorescence endoscopy procedure.
- amendment June 2015: topical administration bevacizumab-800CW (100ug/ml)
Near infrared fluorescence endoscopy platformDevice
A flexible fiber-bundle is attached with its proximal end to a camera which can detect near infrared fluorescent light. The distal end is inserted into the working channel of a clinical video endoscope to visualize the luminal wall. The fluorescent imaging will be performed prior and post the endoscopic resection (within the same endoscopic session)
| Study group | Role | What they receive |
|---|---|---|
| Tracer bevacizumab-IRDye800CW | Experimental | Two days prior to the fluorescence endoscopy procedure (with the near infrared fluorescence endoscopy platform), all patients will receive the fluorescent tracer bevacizumab-IRDye800CW intravenously.
*amendement June 2015: topical administration of bevacizumab-800CW Receives: Drug: Bevacizumab-IRDye800CW; Device: Near infrared fluorescence endoscopy platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIR fluorescent signal in vivo (prior to EMR)
Evaluating presence of specific fluorescent signal in (pre)malignant esophageal lesion in vivo, with use of Near Infrared (NIR) fluorescence endoscopy platform.
Measured: 1 day (endoscopy-day)
Secondary outcomes (4)
Number of participants with adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR).
Data collection as a measure of safety and tolerability regarding administration of Bevacizumab-IRDye800CW
Measured: Two days prior and up to 1 week after administration of tracer
VEGF expression ex vivo
Correlation between specific fluorescent signal in vivo and ex vivo (observed with near-infrared fluorescence endoscopy) and VEGF expression ex vivo (immunohistochemistry).
Measured: up to 1 year
NIR fluorescent signal in vivo (wound bed, post EMR)
Presence of specific fluorescence signal in correlation to histological evaluation of specimen (resection margins)
Measured: 1 day (endoscopy-day)
NIR fluorescent signal ex vivo (biopsy and EMR specimen)
Evaluation of specific fluorescent signal ex vivo in correlation with observed fluorescence signal during endoscopy procedure.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wouter B Nagengast, PharmD MD PhD, Principal investigator, University Medical Center GroningenFrans TM Peters, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129933
- Sponsor's protocol ID
- NL45554.042.14
- Other IDs
- 2013-003003-19
- Acronym
- VICE
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2014
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nagengast WB, Hartmans E, Garcia-Allende PB, Peters FTM, Linssen MD, Koch M, Koller M, Tjalma JJJ, Karrenbeld A, Jorritsma-Smit A, Kleibeuker JH, van Dam GM, Ntziachristos V. Near-infrared fluorescence molecular endoscopy detects dysplastic oesophageal lesions using topical and systemic tracer of vascular endothelial growth factor A. Gut. 2019 Jan;68(1):7-10. doi: 10.1136/gutjnl-2017-314953. Epub 2017 Dec 15. No abstract available.
PubMed 29247063
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Intervention Study for the Use of VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (Pre)Malignant Esophageal Lesions
- ClinicalTrials.gov ID
- NCT02129933
- Acronym / sponsor ID
- VICE / NL45554.042.14
- Conditions
- Esophageal Cancer, Dysplasia
- Keywords
- EAC, HGD, Esophagus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 2 May 2014 (estimated)
- 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.
To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there is a need for better endoscopic visualization and the ability for targeted biopsies. Optical molecular imaging of neoplasia associated biomarkers could form a promising technique to accommodate this need. It is known that the biomarker Vascular Endothelial Growth Factor (VEGF) is overexpressed in dysplastic and neoplastic areas in BE segments versus normal tissue and has proven to be a valid target for molecular imaging. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye IRDye800CW. We hypothesize that when bevacizumab-IRDye800CW is administered, it accumulates in VEGF expressing high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC), enabling early cancer visualization using a newly developed fluorescent NIR fiber-bundle. This hypothesis will be tested in this pilot intervention study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracer bevacizumab-IRDye800CW | Experimental | Drug: Bevacizumab-IRDye800CW, Device: Near infrared fluorescence endoscopy platformTwo days prior to the fluorescence endoscopy procedure (with the near infrared fluorescence endoscopy platform), all patients will receive the fluorescent tracer bevacizumab-IRDye800CW intravenously. *amendement June 2015: topical administration of bevacizumab-800CW |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Identified HGD or intramucosal EAC (T1) and therefore candidate for endoscopic mucosal resection therapy
- Mentally competent person, 18 years or older.
- Written informed consent.
- Adequate potential for follow-up.
Key exclusion criteria (5 listed)
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- Submucosal and invasive EAC; EAC with tumor-classification other than T1.
- Concurrent (uncontrolled) medical conditions which disqualify for an endoscopic mucosal resection procedure.
- Previously performed therapeutic endoscopic procedures.
- Pregnancy or breast feeding.
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 |
|---|---|---|
| Bevacizumab-IRDye800CWAlso: Beva-800CW, Bevacizumab-800CW, Avastin-800CW (Roche)Intravenous administration of a microdose (4.5mg, subtherapeutic) of Bevacizumab-IRDye800CW 2 days prior to the fluorescence endoscopy procedure. * amendment June 2015: topical administration bevacizumab-800CW (100ug/ml) | Drug | Tracer bevacizumab-IRDye800CW |
| Near infrared fluorescence endoscopy platformA flexible fiber-bundle is attached with its proximal end to a camera which can detect near infrared fluorescent light. The distal end is inserted into the working channel of a clinical video endoscope to visualize the luminal wall. The fluorescent imaging will be performed prior and post the endoscopic resection (within the same endoscopic session) | Device | Tracer bevacizumab-IRDye800CW |
Primary outcome
NIR fluorescent signal in vivo (prior to EMR)
Time frame: 1 day (endoscopy-day)
Evaluating presence of specific fluorescent signal in (pre)malignant esophageal lesion in vivo, with use of Near Infrared (NIR) fluorescence endoscopy platform.
4 secondary outcomes
Number of participants with adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR).
Time frame: Two days prior and up to 1 week after administration of tracer
VEGF expression ex vivo
Time frame: up to 1 year
NIR fluorescent signal in vivo (wound bed, post EMR)
Time frame: 1 day (endoscopy-day)
NIR fluorescent signal ex vivo (biopsy and EMR specimen)
Time frame: up to 1 year
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 16 Apr 2024.
- Derived from this study: PubMed 29247063Nagengast WB, Hartmans E, Garcia-Allende PB, Peters FTM, Linssen MD, Koch M, Koller M, Tjalma JJJ, Karrenbeld A, Jorritsma-Smit A, Kleibeuker JH, van Dam GM, Ntziachristos V. Near-infrared fluorescence molecular endoscopy detects dysplastic oesophageal lesions using topical and systemic tracer of vascular endothelial growth factor A. Gut. 2019 Jan;68(1):7-10. doi: 10.1136/gutjnl-2017-314953. Epub 2017 Dec 15. No abstract available.
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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.
Wouter B Nagengast, PharmD MD PhD principal investigator
University Medical Center Groningen
Frans TM Peters, MD PhD principal investigator
University Medical Center Groningen
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 Bevacizumab-IRDye800CW and Near infrared fluorescence endoscopy platform in people with Esophageal Cancer and Dysplasia, 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 5 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 16 Apr 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 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?
NIR fluorescent signal in vivo (prior to EMR) (time frame: 1 day (endoscopy-day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02129933, which also lists 1 linked publication.
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 16 Apr 2024.