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Status unknownNCT03549195Updated Jun 7, 2018

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

An interventional study of ICG and ICG-CP in Cervical Cancer and Sentinel Lymph Node, sponsored by Huazhong University of Science and Technology. Status unknown at 1 site in China. Open to female participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-06-07.

Sponsored by Huazhong University of Science and Technology · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
30 Years to 60 Years
Sex
Female
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Study 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

02

Conditions studied

  • Cervical Cancer
  • Sentinel Lymph Node
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In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 120 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 241 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
Female
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    ICG

    Procedure: ICG

  • Active comparator
    ICG-CP

    CP, control peptide

    Procedure: ICG-CP

  • Experimental
    ICG-TMTP1

    also named as TMTP1-ICG

    Procedure: ICG-TMTP1

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.

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What researchers measure

Primary outcomes

  1. Detection rate of micro-metastasis sentinel lymph node

    Detection of micro-metastasis sentinel lymph node per patient

    Time frame: 7 days

Secondary outcomes

  1. Sensitivity

    Sensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP

    Time frame: 7 days

  2. Specificity

    Specificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG or ICG-CP

    Time frame: 7 days

  3. Incidence of adverse events

    Time frame: 7 days

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Study locations

1 site
  • Tongji Hospital, Tongji Medical College, HUST
    Wuhan, Hubei 430030, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03549195
Lead sponsor
Huazhong University of Science and Technology
Responsible party
Ding Ma (Director, Huazhong University of Science and Technology) — Principal investigator
First posted
Jun 7, 2018
Start date
Jun 1, 2018 (estimated)
Primary completion
Jun 1, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Jun 7, 2018

Study contacts

Danhui H Weng, MD
Contact
weng.dh@gmail.com
02783663351

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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