Skip to content

Fluorescence-guided (Minimally Invasive) resections of Colorectal liver metastases - II (MIMIC-II)

Fluorescence-guided (Minimally Invasive) resections of Colorectal liver metastases - II (MIMIC-II) - MIMIC-II

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56540
Enrollment
52
Registered
2024-01-24
Start date
2024-06-24
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

colorectal liver metastases metastases in the liver from primary colon cancer

Interventions

Preoperative Patients will receive a single dose of 10 mg, 20 mg or 0,5 mg/kg of indocyanine green (ICG) 1 to 7 days prior to surgery. Intraoperative The standard surgical procedure will be perform

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Receiving open or robotic surgery for (multiple) colorectal liver metastases • Eligible for indocyanine green infusion • Pretreated with neoadjuvant chemotherapy (received last cycle of chemotherapy within 3 months before surgery) • Received at least 3 cycles of chemotherapy • Above 18 years of age

Exclusion criteria

Exclusion criteria: • Diagnosed with anything other than colorectal liver metastases after histological examination • Known allergy to indocyanine green • Known allergies to shells and/or clamps • Receiving other types of surgery then open and robotic surgery • Contraindication for indocyanine green (EGFR

Design outcomes

Primary

MeasureTime frame
Back-table signal-to-background ratio in bread loaves

Secondary

MeasureTime frame
Back-table mean fluorescence intensity of signal fluorescence in bread loaves Back-table mean fluorescence intensity of background fluorescence in bread loaves Back-table width of the fluorescent *rim* in bread loaves In vivo signal-to-background ratios Radical resection rates Intraoperative visibility of the lesion(s) based on intraoperative questionnaires - For robotic surgery: Difference between interpretability of the fluorescence in *normal* Firefly mode and in *sensitive* Firefly mode based on intraoperative questionnaires. IHC scoring of Chemotherapy Associated Liver Injury (CALI) and liver function blood analysis Lifetime imaging, IHC, and bread loaf fluorescence correlation

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)