Clinical trial · Interventional
TMTP1-ICG Mapping in Colposcopy-directed Biopsy
Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Colposcopy-directed Biopsy
NCT03321461CI-TRIAL-00052489unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG | Drug | — | UNRESOLVED |
| TMTP1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TMTP1
- description
- The TMTP1-ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. Then TMTP1-ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed.
- interventionNames
- Drug: TMTP1
- type
- ACTIVE_COMPARATOR
- label
- ICG
- description
- The ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed.
- interventionNames
- Drug: ICG
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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.
References
Publications (0)
Data not yet available
No reference posted for this study.