Skip to content

Evaluation of the biosafety and true effectiveness of aggregation-induced luminescent materials

Evaluation of the biosafety and true effectiveness of aggregation-induced luminescent materials

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400083710
Enrollment
Unknown
Registered
2024-04-30
Start date
2024-11-19
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Bladder cancer

Interventions

Index test:Near infrared peptide probe. The equipment models are as follows: 28164 AC, 28164 BC, 28164 FC
Camera host. The equipment models are as follows: GCYJ-F04M-090002
Cold light source. The equipment models are as follows: GCYJ-F23G-090004.

Sponsors

Harbin Medical University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The patients who have fully understood the study and voluntarily signed the written informed consent; 2. Patients with bladder tumor diagnosed by pathology and scheduled for surgical treatment; 3. Patients aged 18-70 years old, regardless of gender; 4. Those with KPS score >= 60; 5. The patients with normal organ function (without continuous support treatment, the laboratory examination results within one week before admission); neutrophils > 1.5 x 10^9 / L, platelets > 100 x 10^9 / L, hemoglobin > 9.0g/dl; normal or < 1.5 x ULN bilirubin; ast (SGOT), ALT (SGPT) < 2.5 x ULN (if liver metastasis, < 5 x ULN); serum creatinine < 1.5 x ULN; 6. Patients with an estimated survival time of 3 months or more.

Exclusion criteria

Exclusion criteria: 1. Patients with urinary system malformation or urethral stricture; 2. Pregnant or lactating subjects; 3. Patients with other serious systemic diseases; 4. Patients who are allergic to a variety of drugs; 5. Those who are participating in or have participated in another clinical study within the last 30 days;

Design outcomes

Primary

MeasureTime frame
Fluorescence intensity of bladder tumor;Accuracy ;

Secondary

MeasureTime frame
Sensitivity ;Specificity ;Positive predicative value;

Countries

China

Contacts

Public ContactWanhai Xu

Harbin Medical University Cancer Hospital

xuwanhai@163.com+86 133 1360 2566

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026