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TMVP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TMVP1-ICG
ICG
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18 years of age, married, without childbearing requirements at the time of consent.
  • FIGO stage IA1-IIB cervical squamous cell 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

Sites / Locations

  • Tongji Hospital, Tongji Medical Colledge, HUSTRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TMVP1

ICG

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Detection rate of sentinel lymph node
Detection of sentinel lymph node per patient

Secondary Outcome Measures

Sensitivity
Sensitivity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG
Specificity
Specificity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG
Incidence of adverse events

Full Information

First Posted
October 22, 2017
Last Updated
October 24, 2017
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03320772
Brief Title
TMVP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer
Official Title
Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Laparoscopic Sentinel Lymph Node Detection in Cervical Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TMVP1
Arm Type
Experimental
Arm Description
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.
Arm Title
ICG
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TMVP1-ICG
Intervention Description
Detection of SLN
Intervention Type
Drug
Intervention Name(s)
ICG
Intervention Description
Detection of SLN
Primary Outcome Measure Information:
Title
Detection rate of sentinel lymph node
Description
Detection of sentinel lymph node per patient
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Sensitivity
Description
Sensitivity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG
Time Frame
7 days
Title
Specificity
Description
Specificity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG
Time Frame
7 days
Title
Incidence of adverse events
Time Frame
7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age, married, without childbearing requirements at the time of consent. FIGO stage IA1-IIB cervical squamous cell 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danhui Weng, Dr.
Phone
027-83663351
Email
weng.dh@gmail.com
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical Colledge, HUST
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juncheng Wei, Dr.
Phone
027-83663351
Email
wjcwjc999@126.com

12. IPD Sharing Statement

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TMVP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer

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