Intraoperative detection of tumor tissue in peritoneal carcinomatosis of colorectal origin using a VEGF-targeted Optical Fluorescent Imaging Tracer. A single centre Pilot study (HI-LIGHT study NL45588)

Intraoperative detection of tumor tissue in peritoneal carcinomatosis of colorectal origin using a VEGF-targeted Optical Fluorescent Imaging Tracer. A single centre Pilot study (HI-LIGHT study NL45588) - VEGF-Targeted NIR imaging in Peritoneal Carcinomatosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40339

Enrollment

Registered

2014-04-09

Start date

2014-07-07

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal peritoneal carcinomatosis

Interventions

Patients scheduled for a HIPEC procedure for peritoneal carcinomatosis of colorectal origin will be consented for this study. There will be three study related visits. During a screening visit (visi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age >= 18 years. • Patients with histopathological proven peritoneal carcinomatosis from colorectal origin who are scheduled to the HIPEC procedure • Patient is considered to be mentally and physically fit for the HIPEC procedure as judged by the responsible physician • WHO performance score 0-2 • Signed written informed consent.

Exclusion criteria

Exclusion criteria: • Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years. • Distance metastasis (liver / lungs) • Medical or psychiatric conditions that compromise the patient*s ability to give informed consent. • Concurrent uncontrolled medical conditions. • Pregnancy or breast feeding. • Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia, e.g. atrial fibrillation, even if controlled with medication) or myocardial infarction within the past 12 months.

Design outcomes

Primary

Measure	Time frame
- Determination of sensitivity ands specificity data of the sampled (non-) fluorescent tissue acquired intraoperatively compared to standard histopathological examination for the presence of tumor tissue. (10 samples per patient). - Localization and (semi) quantification of a fluorescent signal of tumor tissue and surrounding tissue after post-processing of the in vivo required data. - In vivo NIR fluorescence quantification vs. ex vivo VEGF levels in biopsies and additional ex vivo analyses (using immunohistochemistry (IHC).	—

Measure

Time frame

- Determination of sensitivity ands specificity data of the sampled (non-) fluorescent tissue acquired intraoperatively compared to standard histopathological examination for the presence of tumor tissue. (10 samples per patient). - Localization and (semi) quantification of a fluorescent signal of tumor tissue and surrounding tissue after post-processing of the in vivo required data. - In vivo NIR fluorescence quantification vs. ex vivo VEGF levels in biopsies and additional ex vivo analyses (using immunohistochemistry (IHC).

—

Secondary

Measure	Time frame
Improving the detection rate of peritoneal carcinomatosa using MFR imaging, for purposes of better staging by calculating the peritoneal carcinomatosis index (PCI) based on fluorescence detection	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)