Clinical trial · Observational
Deep Learning-Based Intraoperative Dual-tracer Video Analysis of Sentinel Lymph Node Mapping for Metastasis Prediction in cN0 Papillary Thyroid Carcinoma
Deep Learning-Based Intraoperative Dual-tracer Video Analysis of Sentinel Lymph Node Mapping for Metastasis Prediction in cN0 Papillary Thyroid Carcinoma: A Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to learn if a computer program (deep learning) can accurately predict lymph node spread in adults with papillary thyroid cancer who have no signs of lymph node involvement before surgery (called cN0). The main questions it aims to answer are: * Can video analysis of lymph node mapping during surgery predict if cancer has spread to lymph nodes beyond the first-draining (sentinel) lymph node? * Can this prediction help surgeons decide how much tissue to remove during surgery? During surgery, participants will receive an injection of two special dyes (carbon nanoparticles and indocyanine green) near the thyroid tumor. These dyes travel through the lymphatic system and help surgeons see the lymph nodes. A special camera records a video of how the dyes move and light up the lymph nodes. Researchers will use computer programs to analyze these videos along with other medical information (such as ultrasound results and tumor characteristics) to predict whether cancer has spread to additional lymph nodes. The predictions will be compared against the actual results from tissue samples examined after surgery. Participants will receive standard thyroid cancer surgery. The study does not change the surgical treatment. The video recording adds no extra risk to participants.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Papillary Thyroid Carcinoma | Thyroid Gland Papillary Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbon nanoparticle (CNs) sentinel lymph node mapping | Diagnostic Test | — | UNRESOLVED |
| Dual-tracer (ICG combined with CNs) sentinel lymph node mapping | Diagnostic Test | — | UNRESOLVED |
| Indocyanine green (ICG) sentinel lymph node mapping | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- ICG Group
- description
- Adults with clinically node-negative papillary thyroid carcinoma (cN0-PTC) who undergo intraoperative sentinel lymph node mapping using indocyanine green (ICG) alone. Intervention: 0.2 ml of ICG solution (concentration: 2.5 mg/ml) injected at multiple points around the thyroid tumor under ultrasound guidance. Near-infrared fluorescence imaging is used to visualize lymphatic drainage and identify sentinel lymph nodes. Participants undergo standard thyroid surgery including thyroid lobectomy and central lymph node dissection, with additional dissection based on intraoperative findings.
- interventionNames
- Diagnostic Test: Carbon nanoparticle (CNs) sentinel lymph node mapping
- label
- CNs Group
- description
- Adults with clinically node-negative papillary thyroid carcinoma (cN0-PTC) who undergo intraoperative sentinel lymph node mapping using carbon nanoparticles (CNs) alone. Intervention: 0.2 ml of carbon nanoparticle suspension (concentration: 50 mg/ml) injected at multiple points around the thyroid tumor under ultrasound guidance. Black staining is used to visualize lymph nodes during surgery. Participants undergo standard thyroid surgery including thyroid lobectomy and central lymph node dissection, with additional dissection based on intraoperative findings.
- interventionNames
- Diagnostic Test: Indocyanine green (ICG) sentinel lymph node mapping
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years or older at the time of enrollment 2. Histologically confirmed papillary thyroid carcinoma (PTC) by preoperative fine-needle aspiration biopsy 3. Clinically node-negative (cN0) status confirmed by preoperative imaging (ultrasound and/or cross-sectional imaging showing no evidence of lymph node metastasis) 4. Scheduled to undergo thyroid surgery with simultaneous central lymph node dissection 5. Willing and able to provide written informed consent 6. Complete preoperative clinical data available, including: * Demographic information (age, sex, body mass index) * Thyroid ultrasound report with detailed tumor characteristics * Fine-needle aspiration biopsy pathology report * Genetic testing results (when available) 7. Able to undergo intraoperative dual-tracer sentinel lymph node mapping with near-infrared fluorescence video recording Exclusion Criteria: 1. History of previous neck surgery (including thyroid surgery, parathyroid surgery, or other cervical operations) 2. History of external beam radiotherapy to the head and neck region 3. Diagnosis of thyroid malignancy other than papillary thyroid carcinoma (e.g., follicular thyroid carcinoma, medullary thyroid carcinoma, anaplastic thyroid carcinoma, or thyroid lymphoma) 4. Known allergy or hypersensitivity to indocyanine green (ICG), iodine, or carbon nanoparticles 5. Severe hepatic insufficiency (ICG is metabolized by the liver) 6. Pregnancy or breastfeeding 7. Incomplete medical records or missing essential preoperative data 8. Refusal to undergo dual-tracer imaging procedure 9. Inability to obtain satisfactory intraoperative near-infrared fluorescence video recording due to technical issues or poor image quality 10. Participation in another interventional clinical trial that may interfere with the current study 11. Any condition that, in the investigator's opinion, would compromise the participant's safety or the quality of the study data
References
Publications (46)
- RESULTQian T, Zhou Y, Yao J, Ni C, Asif S, Chen C, Lv L, Ou D, Xu D. Deep learning based analysis of dynamic video ultrasonography for predicting cervical lymph node metastasis in papillary thyroid carcinoma. Endocrine. 2025 Mar;87(3):1060-1069. doi: 10.1007/s12020-024-04091-w. Epub 2024 Nov 18. PMID 39556263
- RESULTDing X, Liu Y, Zhao J, Wang R, Li C, Luo Q, Shen C. A novel wavelet-transform-based convolution classification network for cervical lymph node metastasis of papillary thyroid carcinoma in ultrasound images. Comput Med Imaging Graph. 2023 Oct;109:102298. doi: 10.1016/j.compmedimag.2023.102298. Epub 2023 Sep 9. PMID 37769402
- RESULTYang D, Li T, Li L, Chen S, Li X. Multi-modal convolutional neural network-based thyroid cytology classification and diagnosis. Hum Pathol. 2025 Jul;161:105868. doi: 10.1016/j.humpath.2025.105868. Epub 2025 Jul 4. PMID 40617519
- RESULTChu X, Wang T, Chen M, Li J, Wang L, Wang C, Wang H, Wong ST, Chen Y, Li H. Deep learning model for malignancy prediction of TI-RADS 4 thyroid nodules with high-risk characteristics using multimodal ultrasound: A multicentre study. Comput Med Imaging Graph. 2025 Sep;124:102576. doi: 10.1016/j.compmedimag.2025.102576. Epub 2025 May 26. PMID 40446583
- RESULTLiang M, Zhu T, Huang N, Zhang L, Yang C, Gao H, Zhang X, Li P, Cheng M, Wang K. Incorporating sentinel chain involvement pattern to predict non-sentinel lymph nodes status in breast cancer after neoadjuvant chemotherapy. Clin Transl Oncol. 2026 Jan;28(1):203-214. doi: 10.1007/s12094-025-03993-z. Epub 2025 Jul 31. PMID 40745244
- RESULTMittendorf EA, Hunt KK, Boughey JC, Bassett R, Degnim AC, Harrell R, Yi M, Meric-Bernstam F, Ross MI, Babiera GV, Kuerer HM, Hwang RF. Incorporation of sentinel lymph node metastasis size into a nomogram predicting nonsentinel lymph node involvement in breast cancer patients with a positive sentinel lymph node. Ann Surg. 2012 Jan;255(1):109-15. doi: 10.1097/SLA.0b013e318238f461.