Status:

UNKNOWN

TMTP1-ICG Mapping in Colposcopy-directed Biopsy

Lead Sponsor:

Huazhong University of Science and Technology

Conditions:

Cervical Intraepithelial Neoplasia

Eligibility:

FEMALE

18-60 years

Phase:

PHASE1

Brief Summary

Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.

Eligibility Criteria

Inclusion

  • Suspicious of cervical disease required a colposcopy-directed biopsy.
  • Subjects must sign an informed consent indicating awareness of the investigational nature of this study.

Exclusion

  • 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.

Key Trial Info

Start Date :

November 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2021

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT03321461

Start Date

November 1 2017

End Date

December 1 2021

Last Update

June 30 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Tongji Hospital, Tongji Medical Colledge, HUST

Wuhan, Hubei, China, 430030