rectal cancer
Conditions
Interventions
Patients included in this study will be administered Bevacizumab-IRDye800CW
intraveneously in tracer dose (4.5 mg in 5 ml) and observed for one hour. Two
days after tracer administration patients un
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with locally advanced rectal cancer. - Rectal cancer, in multi disciplinary colorectal oncology meeting agreed on long course neoadjuvant chemoradiotherapy or neoadjuvant treatment according to RAPIDO trial. - Age * 18 years. - Written informed consent.
Exclusion criteria
Exclusion criteria: - Medical or psychiatric conditions that compromise the patient*s ability to give informed consent. - Concurrent uncontrolled medical conditions. - Pregnancy or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine the sensitivity of the marker bevacizumab-IRDye800CW using innovative NIR fluorescence endoscopy (visualizing with wide-field endoscopy, measuring with MDSFR/SFF spectroscopy and optionally visualizing with optoacoustic endoscopy), in identifying target expression and heterogeneity prior to the start and after neoadjuvant treatment. Research aims to assess primary objectives Evaluation of wide-field, spectroscopy and opto-acoustic images - Determine positive and negative fluorescent areas of wide-field fluorescence images - Quantify fluorescence signal of the tumour, tumour margins and surrounding tissue using MDSFR/SFF spectroscopy - Determine and (semi)quantify fluorescence intensities in deeper (malignant) tissue using opto-acoustic endoscopy Evaluation of biopsy and surgical specimen - Identify VEGF expression and heterogeneity - Assess the (sub-)cellular location of bevacizumab-IRDye800CW and determine fluorescence intensity in biopsy specimen using fluorescence microscopy - Correlate determined fluorescence (in vivo and ex vivo) to histology, VEGF expression and VEGF heterogeneity. Evaluation of safety aspects - To obtain information on safety aspects of the tracer, side effects, adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this study are: - Study if fluorescence endoscopy can evaluate treatment response after neoadjuvant treatment, just prior to surgery. - Study if there is a correlation between the outcome of fluorescence endoscopy and other biological and molecular parameters. - Study if there is a correlation between the outcome of fluorescence endoscopy and circulating tumour DNA. Research aims to assess secondary objectives Next to the research aims used to assess the primary objective, the following are used: - Assess correlation between outcome of fluorescence endoscopy and pathologic response. - Characterize circulating tumour DNA over time. - IHC, DNA, RNA and protein analyses on circulating tumour DNA and biopsy and surgical specimen. | — |
Countries
Netherlands
Outcome results
None listed