TMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN Detection in Cervical Cancer
|ClinicalTrials.gov Identifier: NCT03549195|
Recruitment Status : Unknown
Verified May 2018 by Ding Ma, Huazhong University of Science and Technology.
Recruitment status was: 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549195
|Contact: Danhui H Weng, MDfirstname.lastname@example.org|
|Tongji Hospital, Tongji Medical College, HUST|
|Wuhan, Hubei, China, 430030|
|Contact: Danhui Weng, MD 02783663351 ext 02783663351 email@example.com|