Sentinel lymph node identification in colon and rectal cancer using a radioactive and fluorescent tracer

Sentinel lymph node identification in colon and rectal cancer using a radioactive and fluorescent tracer - SLN in colon and rectal cancer using a multimodal tracer

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41306

Enrollment

Registered

2014-06-27

Start date

2014-07-01

Completion date

Unknown

Last updated

2025-02-10

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

Conditions

Colorectal cancer sentinel lymph node

Interventions

The proposed study is a prospective feasibility study to demonstrate the feasibility of SLN mapping by using a radioactive and fluorescent tracer. Study setting: The proposed study will be conducte

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Oral and written informed consent - Age 18 years and older - Colon cancer (Tis-T1-T2-T3) - Laparoscopic surgical resection of the tumour - Regular pre-operative work-up - Rectal cancer with no indication for neoadjuvant treatment -

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 - 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 cancer with indication for neoadjuvant therapy

Design outcomes

Primary

Measure	Time frame
Identification rate of SLNM with preoperative PET/CT imaging and intraoperative NIR fluorescence imaging in patients with colon and rectal cancer.	—

Secondary

Measure	Time frame
• Preoperative detection rate of SLNs by PET/CT scan • Number of SLNs seen by PET/CT scan at different time points after tracer injection • Adaptive value of preoperative localization of SLNs by PET/CT imaging during the surgical procedure. • Number and location of SLNs detected by NIR fluorescence imaging in vivo and ex vivo • Determination of the optimal volume of 89Zr-Nanocoll • Determination of the optimal preoperative injection time for 89Zr-Nanocoll • Visualization of lymphatic vesselsand the possibility of differentiation between first and second echelon lymph nodes. • Pathological status of the detected (S)LNs. • Amount of metastasis in positive lymph nodes. - Differences in kinetics of the tracer between colon and rectal cancer - Differences in detection rate of the SLN between colon and rectal cancer	—

Measure

Time frame

• Preoperative detection rate of SLNs by PET/CT scan • Number of SLNs seen by PET/CT scan at different time points after tracer injection • Adaptive value of preoperative localization of SLNs by PET/CT imaging during the surgical procedure. • Number and location of SLNs detected by NIR fluorescence imaging in vivo and ex vivo • Determination of the optimal volume of 89Zr-Nanocoll • Determination of the optimal preoperative injection time for 89Zr-Nanocoll • Visualization of lymphatic vesselsand the possibility of differentiation between first and second echelon lymph nodes. • Pathological status of the detected (S)LNs. • Amount of metastasis in positive lymph nodes. - Differences in kinetics of the tracer between colon and rectal cancer - Differences in detection rate of the SLN between colon and rectal cancer

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)