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

Novel Tumor Targeted Fluorescent Peptide TMTP1-ICG Mapping in Laparoscopic Sentinel Micro-metastasis Lymph Node Detection in Cervical Cancer Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03549195
Enrollment
120
Registered
2018-06-07
Start date
2018-06-01
Completion date
2019-12-31
Last updated
2018-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Sentinel Lymph Node

Brief 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

Interventions

PROCEDUREICG

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

PROCEDUREICG-CP

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

PROCEDUREICG-TMTP1

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

Sponsors

Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Detection rate of micro-metastasis sentinel lymph node7 daysDetection of micro-metastasis sentinel lymph node per patient

Secondary

MeasureTime frameDescription
Sensitivity7 daysSensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP
Specificity7 daysSpecificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP
Incidence of adverse events7 days—

Countries

China

Contacts

Primary ContactDanhui H Weng, MD
weng.dh@gmail.com02783663351

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026