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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03549195
Other study ID # TMTP1-ICG-03
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date December 31, 2019

Study information

Verified date May 2018
Source Huazhong University of Science and Technology
Contact Danhui H Weng, MD
Phone 02783663351
Email weng.dh@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators aimed to determine the validity of the investigator's novel tumor targeted fluorescent peptide TMTP1-ICG to increased accuracy of laparoscopic SLN mapping


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date December 31, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria:

- Without childbearing requirements at the time of consent.

- FIGO stage IB1, IIA1 cervical cancer and is a candidate for laparoscopy intervention, with lymph node dissection being a part of the surgical plan.

- Subject has provided written informed consent.

Exclusion Criteria:

- Breast-feeding or pregnant.

- Ongoing participation in another clinical trial with an investigational drug with 3 months

- Own allergy towards ICG and/or alcohol

- Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases

- Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency

Study Design


Intervention

Procedure:
ICG
The ICG powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
ICG-CP
The ICG-CP powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
ICG-TMTP1
The ICG-TMTP1 powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.

Locations

Country Name City State
China Tongji Hospital, Tongji Medical College, HUST Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detection rate of micro-metastasis sentinel lymph node Detection of micro-metastasis sentinel lymph node per patient 7 days
Secondary Sensitivity Sensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP 7 days
Secondary Specificity Specificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP 7 days
Secondary Incidence of adverse events 7 days
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