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A Phase II Clinical Study Evaluating the Effectiveness of Injectable NC527-X in Intraoperative Imaging for Patients With Solid Tumors

NCT07538648 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-04-20

No results posted yet for this study

Summary

Evaluate the initial dose-effect and time-effect relationship of the injection product NC527-X

Conditions

Interventions

DRUG

Experimental:Preoperative injection of NC527-X

This study will set up four single-arm dose groups (A, B, C, D), and it will be conducted in patients with solid tumors who have been diagnosed and are scheduled for surgical resection (evaluated by the researchers to have no surgical contraindications). The study will initially assign patients to groups A, B, C, and D respectively, with each group planning to include at least 3 cases, and a total of no more than 100 cases will be enrolled. The dosages will be 0.005 mg/kg, 0.01 mg/kg, 0.02 mg/kg, and 0.04 mg/kg, and the imaging time window after administration will be 24 to 72 hours.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-24
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07538648 on ClinicalTrials.gov