TMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN Detection in Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT03549195|
Recruitment Status : Not yet recruiting
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Sentinel Lymph Node||Procedure: ICG Procedure: ICG-CP Procedure: ICG-TMTP1||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel Tumor Targeted Fluorescent Peptide TMTP1-ICG Mapping in Laparoscopic Sentinel Micro-metastasis Lymph Node Detection in Cervical Cancer Patients|
|Estimated Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||December 31, 2019|
|Active Comparator: ICG||
The ICG powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
Active Comparator: ICG-CP
CP, control peptide
The ICG-CP powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
also named as TMTP1-ICG
The ICG-TMTP1 powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
- Detection rate of micro-metastasis sentinel lymph node [ Time Frame: 7 days ]Detection of micro-metastasis sentinel lymph node per patient
- Sensitivity [ Time Frame: 7 days ]Sensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP
- Specificity [ Time Frame: 7 days ]Specificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP
- Incidence of adverse events [ Time Frame: 7 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549195
|Contact: Danhui H Weng, MDemail@example.com|
|Tongji Hospital, Tongji Medical College, HUST||Not yet recruiting|
|Wuhan, Hubei, China, 430030|
|Contact: Danhui Weng, MD 02783663351 ext 02783663351 firstname.lastname@example.org|