The aim of this present feasibility study is to determine the safety and preliminary accuracy by which we can intra-operatively detect residual disease in esophageal tumor and lymph nodes. This study is set up as a prospective multi-centre dose…
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Intra-operative accumulation of bevacizumab-800CW in VEGF-A overexpressed
tissue as detected with fluorescence imaging and histological analyses
• Adverse events (AE), serious adverse events (SAE), and suspected unexpected
serious and adverse reactions (SUSARs).
Secondary outcome
• Number of patients in whom lymph node metastases can be visualized by
fluorescence imaging during surgery
• Fluorescence signal in malignant and non-malignant tissue:
single-to-background ratio and tumor-to-normal ratio as measured by ex-vivo
fluorescence measurements
• Correlation between localization of the fluorescently-labeled antibody and
expression of the biomarker in tumor and healthy tissue
Background summary
There is a need for better visualization of resection margins and detection of
small tumor deposits during surgery for esophageal cancer. Optical molecular
imaging of esophageal adenocarcinoma (EAC) associated biomarkers is a promising
technique to accommodate this need. The biomarker Vascular Endothelial Growth
Factor (VEGF-A) is overexpressed in esophageal adenocarcinoma and its lymph
node metastases and has proven to be a valid target for molecular imaging. We
hypothesize that Bevacizumab-800 CW accumulates in VEGF-A expressing cancer,
enabling esophageal cancer visualization using a NIR minimally invasive
intra-operative camera system. In this pilot intervention study we will
determine the optimal dosage of Bevacizumab-800 CW (4.5, 10 or 25 mg) to
detect esophageal cancer tissue intra-operatively.
Study objective
The aim of this present feasibility study is to determine the safety and
preliminary accuracy by which we can intra-operatively detect residual disease
in esophageal tumor and lymph nodes. This study is set up as a prospective
multi-centre dose finding trial, using a single arm
Study design
Non-randomised multicenter feasibility and dose escalation trial.
Study burden and risks
Time investment for study participants
Esophageal cancer patients who are scheduled for surgery with curative intent
either at Radboudumc or UMCG are asked to participate in this trial. One study
specific visit for administration of the tracer is necessary. In addition to
the surgical procedure the study related procedures are expected to take up to
30 minutes extra as compared to regular practice.
Risks for study participants
In this study, risks to study participants are mainly related to the
administration of the tracer. Safety data related to the administration of the
tracer will be collected and evaluated. Based on previous research (breast
cancer NCT01508572; adenomatous poliposis coli NCT02113202; rectal cancer
NCT01972373; and in esophageal cancer dysplasia NCT02129933) no adverse events
are expected following administration of bevacizumab-800 CW. The normal
treatment, esophagectomy, is an extensive procedure with a substantial risk of
complications[1]. Interference with standard clinical care is not expected
since the surgeons will follow their normal standard of care during surgery.
The intra-operative fluorescence imaging is derived during a minimal invasive
procedure and will increase the surgical time by approximately 30 minutes. It
is up to the surgeon to reduce the imaging time during surgery if the study
procedures takes longer than expected. If the extra time of the surgery
interferes with the safety of the patient the research protocol is terminated.
Benefits for study participants
The addition of intra-operative fluorescence imaging does not have direct
benefits for the participating patients. If fluorescent signals are detected
during surgery in parts that are not enclosed in the regular surgical specimen,
a maximum of 2 biopsies per fluorescent area may be taken to confirm during
ex-vivo analyses if the fluorescent signals represent cancer tissue.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
* Age >= 18 years.
* Patients with clinical suspicion of esophageal adenocarcinoma who are
scheduled to undergo surgical intervention with curative intent
* WHO performance score 0-2.
* Signed written informed consent
Exclusion criteria
• Known hypertension to bevacizumab or other monoclonal antibody therapies
• Other invasive malignancy
• Inadequately controlled hypertension
• Squamous cell carcinoma
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-002790-19-NL |
| CCMO | NL61189.042.18 |
| OMON | NL-OMON25371 |