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Coaxial projective imaging for sentinel lymph node mapping in melanoma

Coaxial projective imaging for sentinel lymph node mapping in melanoma

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040572
Enrollment
Unknown
Registered
2020-12-02
Start date
2020-03-01
Completion date
Unknown
Last updated
2021-03-15

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

Conditions

melanoma

Interventions

Gold Standard:immunohistochemical pathology of lymph nodes
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Sponsors

The First Affiliated Hospital of University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) The clinical stage of the patient is T1 and T2 cutaneous melanoma; the primary lesions of the patient are confirmed by the pathological diagnosis as primary skin malignant melanoma; (2) After the clinical physical examination by more than 2 doctors before the operation, no signs of clinical metastasis were found in the regional lymph nodes; (3) The patient will receive at least one imaging evaluation, such as Doppler ultrasound, enhanced CT, enhanced magnetic resonance imaging (MRI) and PET/CT, etc., to confirm that there are no signs of distant metastasis and regional lymph node metastasis, and some highly suspicious patients require puncture cytology to exclude metastases.

Exclusion criteria

Exclusion criteria: (1) Iodine/ICG allergy patients; (2) Pregnancy; (3) Patient with a skin disease who cannot receive laser irradiation; (4) Patient who undergoes an assessment of the overall condition before surgery confirms that he/she cannot tolerate extensive resection of the primary tumor, sentinel biopsy of regional lymph nodes, regional lymph node dissection, and the corresponding anesthesia; (5) Patients who have an adverse reaction and terminate the treatment are not included in the curative effect but included in the incidence of adverse reactions.

Design outcomes

Primary

MeasureTime frame
Number of sentinel lymph nodes with fluorescence;Location of sentinel lymph node with fluorescence;Sentinel node detection rate;False negative rate of sentinel lymph node;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactLiping Zhao

The First Affiliated Hospital of University of Science and Technology of China

zhlip16@163.com+86 0551-62283282

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026