NCT05087264

Brief Summary

Indocyanine green was injected intravenously into patients with cervical cancer before operation. The nerve development was observed by infrared imaging system during operation, which was used as the basis for nerve preserving operation of type C cervical cancer. The recovery of bladder function was observed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Mar 2022

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2025

Completed
Last Updated

March 18, 2022

Status Verified

September 1, 2021

Enrollment Period

3.6 years

First QC Date

September 25, 2021

Last Update Submit

March 17, 2022

Conditions

Cervical Carcinoma

Keywords

Cervical CarcinomaIndocyanine greenNeural phenomenonInfrared imaging

Outcome Measures

Primary Outcomes (1)

  • Main indicators of bladder function recovery

    Residual urine volume of bladder 7 days after operation

    7 days after operation

Secondary Outcomes (1)

  • Other indicators of bladder function recovery

    12, 24 and 48 weeks after operation

Study Arms (2)

Indocyanine green injection

EXPERIMENTAL

43 cases received preoperative intravenous injection of indocyanine green and radical resection of q-mc1 cervical cancer under pelvic autonomic nerve fluorescence development

Drug: Indocyanine green

Not Indocyanine green injection

NO INTERVENTION

43 cases underwent routine surgery，not indocyanine green injection

Interventions

Indocyanine greenDRUG

ICG retention test and clearance test: intravenous injection, 0.5mg/l. Liver blood flow measurement: intravenous drip, dissolve 25mg ICG in 100ml injection water, and drip at a constant speed for about 50min to make the ICG concentration reach equilibrium.

Indocyanine green injection

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subjects have certain reading ability, can communicate effectively with the researchers, and voluntarily sign the informed consent form
  • they are 18-75 years old (including the boundary value) and the ECoG score is 0-1
  • Patients with newly diagnosed cervical squamous epithelial carcinoma and cervical adenocarcinoma confirmed by histology
  • according to NCCN guidelines, they are suitable for patients undergoing radical resection of q-m C1 cervical cancer, i.e. IB1 stage deep interstitial infiltrators / ib2-iia2 stage and early IIB stage
  • normal range of liver and kidney function: bilirubin ≤ 1.5 times ULN, ALT and AST ≤ 2.5 times ULN, creatinine ≤ 1.5 times ULN, Or creatinine clearance rate ≥ 50ml / min (using standard Cockroft Gault formula)
  • have good review and follow-up conditions, and be followed up for at least 1 year

You may not qualify if:

  • The preoperative clinical stage was unclear and the surgical indications were controversial
  • Previous history of malignant tumor or radiotherapy or chemotherapy or antiangiogenic therapy
  • pathological types are neuroendocrine carcinoma, small cell tumor, clear cell carcinoma, sarcoma and other histological types
  • urinary disease obstruction and hydronephrosis
  • severe congestive heart failure of grade II or above of New York Heart Association, History of myocardial infarction or unstable angina pectoris within 6 months before operation; Stroke or transient ischemic attack within 6 months before operation
  • pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FifthSunYetSen

Zhuhai, Guangdong, 519000, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

HL Nie

CONTACT

1353958628895862456@qq.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental group, control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2021

First Posted

October 21, 2021

Study Start

March 10, 2022

Primary Completion

October 16, 2025

Study Completion

October 16, 2025

Last Updated

March 18, 2022

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)