TMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN Detection in Cervical Cancer

NCT ID: NCT03549195

Last Updated: 2018-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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Conditions

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Cervical Cancer Sentinel Lymph Node

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICG

Group Type ACTIVE_COMPARATOR

ICG

Intervention Type PROCEDURE

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

ICG-CP

CP, control peptide

Group Type ACTIVE_COMPARATOR

ICG-CP

Intervention Type PROCEDURE

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

also named as TMTP1-ICG

Group Type EXPERIMENTAL

ICG-TMTP1

Intervention Type PROCEDURE

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

Interventions

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ICG

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Ding Ma

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tongji Hospital, Tongji Medical College, HUST

Wuhan, Hubei, China

Site Status

Countries

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China

Central Contacts

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Danhui H Weng, MD

Role: CONTACT

02783663351

Facility Contacts

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Danhui Weng, MD

Role: primary

02783663351 ext. 02783663351

Other Identifiers

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TMTP1-ICG-03

Identifier Type: -

Identifier Source: org_study_id

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