Sentinel lymph node identification in colon cancer using the hybrid tracer ICG- 99mTc-nanocoll

Sentinel lymph node identification in colon cancer using the hybrid tracer ICG- 99mTc-nanocoll - SLN in colon cancer using ICG-99mTc-nanocolloid

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46140

Enrollment

Registered

2016-04-21

Start date

2016-10-11

Completion date

Unknown

Last updated

2024-11-18

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

Conditions

Colon cancer sentinel lymph node

Interventions

Patients will be injected with the tracer 99mTc-Nanocoll-ICG respectively 5 or 14 hrs before surgery. The tracer will be administrated by colonoscopy performed by the gastroenterologist and injected

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Oral and written informed consent Age 18 years and older Preoperative tumor stage colon cancer (Tis-T1-T2) Laparoscopic surgical resection of the tumor Regular pre-operative work-up

Exclusion criteria

Exclusion criteria: - Patients younger than 18 years - Patients who are legally or mentally incapable or unable to give informed consent - Gross lymph node involvement - Invasion of the tumour in surrounding tissue - Distant metastases - Tumours > 5 cm estimated during preoperative diagnostics - T3 / T4 or metastatic disease discovered during intraoperative staging - Contraindications to laparoscopic surgery - Patients at higher risk for anaphylactic reactions - Pregnancy - Recent myocardial infarction - Allergy for iodine - Claustrophobia - Rectal carcinoma

Design outcomes

Primary

Measure	Time frame
Number of patients upstaged with the SLN procedure	—

Secondary

Measure	Time frame
- Preoperative detection rate of SLNs by SPECT/CT scan - Adaptive value of preoperative localization of SLNs by SPECT/CT imaging during the surgical procedure. - Number of injection failures - Duration of SLN procedure - Implementation of the SLN procedure in the conventional surgical procedure - Adaptive value and capability of the SLN procedure for the surgeon - Adaptive value of gamma-probe in detection of the SLNs - Number and location of SLNs detected by NIR fluorescence imaging - Visualization of lymphatic vessels and the possibility of differentiation between first and second echelon lymph nodes. - Pathological status of the detected SLNs. - Optimale time-frame for SPECt-CT scan after 99mTc-nanocoll injection.	—

Measure

Time frame

- Preoperative detection rate of SLNs by SPECT/CT scan - Adaptive value of preoperative localization of SLNs by SPECT/CT imaging during the surgical procedure. - Number of injection failures - Duration of SLN procedure - Implementation of the SLN procedure in the conventional surgical procedure - Adaptive value and capability of the SLN procedure for the surgeon - Adaptive value of gamma-probe in detection of the SLNs - Number and location of SLNs detected by NIR fluorescence imaging - Visualization of lymphatic vessels and the possibility of differentiation between first and second echelon lymph nodes. - Pathological status of the detected SLNs. - Optimale time-frame for SPECt-CT scan after 99mTc-nanocoll injection.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)