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Sentinel lymph node (SLN) mapping is an acceptable surgical strategy determine whether to perform radical lymphadenectomy in patients with early-stage cervical cancer. Investigators aim to determine the validity of this technique with our novel tumor targeted fluorescent TMVP1-ICG to increased accuracy of SLN mapping.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMVP1 | Experimental | The TMVP1-ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. 0.4ml of TMVP1-ICG solution was injected into the cervix, divided into 3 and 9 o'clock position, in the operating room. During the laparoscopy, the PinPoint S1 Novadaq (PinPoint Endoscopic Fluorescence Imaging System, NOVADAQ, Mississauga, ON, Canada), 30° laparoscopes were used for fluorescent detection. |
|
| ICG | Active Comparator | The ICG powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. 0.4ml of this ICG solution was injected into the cervix, divided into 3 and 9 o'clock position, in the operating room. During the laparoscopy, the PinPoint S1 Novadaq (PinPoint Endoscopic Fluorescence Imaging System, NOVADAQ, Mississauga, ON, Canada), 30° laparoscopes were used for fluorescent detection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMVP1-ICG | Drug | Detection of SLN |
| |
| ICG |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of sentinel lymph node | Detection of sentinel lymph node per patient | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Sensitivity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG | 7 days |
| Specificity | Specificity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danhui Weng, Dr. | Contact | 027-83663351 | weng.dh@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical Colledge, HUST | Recruiting | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Drug |
Detection of SLN |
|
| 7 days |
| Incidence of adverse events | 7 days |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |