Lymph Node Metastases Clinical Trial
Official title:
Detection of Thyroid Cancer and Central Lymph Node Metastases Using EMI-137 Enhanced Molecular Fluorescent Guided Imaging: a Multicentre Feasibility and
Almost 50 % of papillary thyroid cancer (PTC) patients have central lymph node metastases (CLNM), which are associated with a high risk of persistent or recurrent disease. However, the practice of performing a prophylactic central lymph node dissection (PCLND) routinely remains controversial. The proponents argue that without a PCLND, PTC patients with positive lymph nodes have an increased risk of local recurrence, and postponed node dissection leads to with 5-6 fold higher risk of morbidity. If performed, PCLND in clinical node negative patients increases staging to pN1 in more than 50% of the cases without increasing survival. The complication rate in PCLND is lower when compared to a technically challenging re-exploration in recurrent disease, with reported incidences of 0.6% and 7.3-20%, respectively. Opponents of routine PCLND point out the lack of randomized clinical trials and object to treatment-induced hypo-parathyroidism and recurrent nerve damage for the N0 patients. Currently, no diagnostic tool is available which reliably identifies these patient categories. Therefore, there is a clear need for novel diagnostic imaging modalities that overcome this issue. Molecular Fluorescence Guided Surgery (MFGS) is potentially such a diagnostic tool. The administration of NIR fluorescent tracers can increase detection accuracy of cancer and nodal metastatic tissue using macroscopic MFGS. Therefore, we aimed to identify a GMP-produced near infrared (NIR) tracer that potentially has a high target-to-background ratio in PTC compared to normal thyroid tissue. Tyrosine-protein kinase Met (c-Met) is significantly upregulated at the protein level in PTC compared to normal thyroid tissue. The investigators therefore hypothesize that the GMP-produced NIR-fluorescent tracer EMI-137 (targeting c-Met, peak emission at 675 nm range) might be useful for intraoperative imaging of PTC and nodal metastases. The investigators' aim is to investigate if the administration of EMI-137 is a feasible approach to detect PTC nodal metastases. Ultimately, this method might be useful to improve patient selection for CLND. Eventually, we might also be able to visualize multifocality, more selective lateral neck dissections and asses residual tissue after thyroidectomy. Ultimately, all of these strategies may reduce overtreatment, morbidity, and costs while maintaining the same or better effectiveness with a lower recurrence rate and improved quality of life.
See brief summary ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03280719 -
Whole Breast + Lymph Node Irradiation: Prone Compared to Supine Position in 15 or 5 Fractions
|
N/A | |
Active, not recruiting |
NCT04300673 -
Radio Guided Lymph Node Dissection in Oligometastatic Prostate Cancer Patients
|
Phase 1/Phase 2 | |
Completed |
NCT04260139 -
Lymph Node Yield in Colon Cancer Resection Specimens
|
||
Not yet recruiting |
NCT03632746 -
Verifying the Specificity of a New Method in Predicting Lymph Node Metastasis in Early Gastric Cancer Patients
|
||
Active, not recruiting |
NCT03776591 -
Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer
|
N/A | |
Recruiting |
NCT05078853 -
Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma
|
||
Recruiting |
NCT03715686 -
To Accurately Assess Lymph Node Response to NACT by Wire Localization of Clip-marked Lymph Nodes
|
N/A | |
Recruiting |
NCT03280134 -
A Prospective Validation Cohort Study of a Prediction System on nSLN Metastasis in Early Breast Cancer
|
N/A | |
Recruiting |
NCT04117139 -
The Diagnostic Value of PET/MRI in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT04882618 -
Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.
|
Phase 4 | |
Recruiting |
NCT05670574 -
Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors
|
N/A | |
Active, not recruiting |
NCT04611997 -
IGG Using in Laparoscopic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy
|
Phase 3 | |
Recruiting |
NCT04744506 -
Targeted Resection of Axillary Metastatic Lymph Nodes After Breast Cancer Neoadjuvant Chemotherapy
|
N/A | |
Recruiting |
NCT03830242 -
Diagnostic Significance of FDG PET/CT Dynamic Imaging in Detecting Metastatic Lymph Nodes With Papillary Thyroid Cancer.
|
N/A | |
Recruiting |
NCT04959604 -
Lymph Node Mapping Via Flourescent Dye in Colon Cancer
|
N/A | |
Active, not recruiting |
NCT04419935 -
Lymphadenectomy in NSCLC With and Without Adjuvant Therapy
|
||
Enrolling by invitation |
NCT04322331 -
Tumor Immune Mechanism of Axillary Lymph Node Metastasis in Early Luminal Type A Breast Cancer
|
||
Recruiting |
NCT03868215 -
Use of Plasma ctDNA Methylation Haplotypes in Detecting Local Residual or Lymph Node Metastasis
|
||
Recruiting |
NCT04337333 -
Two-in-one Covered and Uncovered Metal Stent
|
N/A | |
Completed |
NCT04068636 -
Sentinel Node in Larynx and Pharynx Cancers
|
N/A |