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Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMTP1 | Experimental | The TMTP1-ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. Then TMTP1-ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed. |
|
| ICG | Active Comparator | The ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMTP1 | Drug | Fluorescent sites will be removed |
| |
| ICG |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Sensitivity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity | Specificity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG | 7 days |
| Incidence of adverse events | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical Colledge, HUST | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| Drug |
Fluorescent sites will be removed |
|
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |