A randomized controlled trial to compare near-infrared fluorescence imaging with standard-of-care sentinel lymph node mapping in vulvar cancer patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25423

Enrollment

Registered

2018-12-25

Start date

2016-06-22

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Vulvar carcinoma, sentinel node mapping, ICG, fluorescence imaging

Interventions

Patients will be randomized by computer into 2 groups. Standard-of-care SLN mapping implies 3-4 peritumoral intracutaneous injections of approximately 0.5ml 30-100MBq 99mTc-nanocolloid 3-24 hours befo

Eligibility

Inclusion criteria

Inclusion criteria: • T1 squamous cell carcinoma of the vulva (FIGO staging 2009), with a depth of infiltration >1 mm, 55); • Absence of any physiological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial; • Age ≥ 18 years; • Written informed consent must be given according to ICH/GCP, national and local regulations.

Exclusion criteria

Exclusion criteria: • Patients with multifocal tumors of the vulva; • Patients who show enlarge (>1.5cm)/suspicious lymph nodes at preoperative imaging; • Patients with a history of vulvar cancer or previously performed SLN procedure/groin operation that might hamper SLN identification; • Allergy to iodine, patent blue, shellfish or ICG; • Pregnancy.

Design outcomes

Primary

Measure	Time frame
The percentage of intraoperative visualized SLNs in vulvar cancer patients who receive standard-of-care SLN mapping using 99mTc and patent blue compared to patients who receive a pre-operative injection of ICG:99mTc without patent blue.	—

Secondary

Measure	Time frame
1. Correlation between NIR fluorescent, or blue and radioactive SLNs; 2. Identification & resection rate of SLNs and non-SLNs; 3. Non-invasive (percutaneous) lymphatic vessel and SLN identification in case of NIR fluorescence imaging; 4. Several time intervals during surgery, such as time until SLN identification, time until SLN resection and total time of the procedure; 5. Number of failures to find the SLN; difference in number of LNs on lymphoscintigraphy and intra-operative SLN detection; 6. Size of skin incision used for SLN biopsy; 7. Number of positive resection margins (i.e. R1 resection) in both groups; 8. Evaluation of the SLN procedure by the surgeon by a short questionnaire; 9. Short-term morbidity, defined as wound breakdown/wound infection and lymphocyst formation 6 weeks after surgery until 1 year.	—

Measure

Time frame

1. Correlation between NIR fluorescent, or blue and radioactive SLNs; 2. Identification & resection rate of SLNs and non-SLNs; 3. Non-invasive (percutaneous) lymphatic vessel and SLN identification in case of NIR fluorescence imaging; 4. Several time intervals during surgery, such as time until SLN identification, time until SLN resection and total time of the procedure; 5. Number of failures to find the SLN; difference in number of LNs on lymphoscintigraphy and intra-operative SLN detection; 6. Size of skin incision used for SLN biopsy; 7. Number of positive resection margins (i.e. R1 resection) in both groups; 8. Evaluation of the SLN procedure by the surgeon by a short questionnaire; 9. Short-term morbidity, defined as wound breakdown/wound infection and lymphocyst formation 6 weeks after surgery until 1 year.

—

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)