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An Open-label, Single-arm, Single-center Study to Evaluate the Diagnostic Efficacy of a Novel PET Probe, 68Ga-SFB6-ZN01, in Patients With Malignant Tumors

NCT07420036 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-03-03

No results posted yet for this study

Summary

This study is being done to test a new imaging agent called 68Ga-SFB6-ZN01, which helps visualize tumors using PET/CT scans. The agent attaches to a protein called integrin αvβ6, which is found on the surface of many cancer cells but rarely on normal cells. A total of 98 adults who either have a confirmed cancer diagnosis, are strongly suspected of having cancer, or may have recurrent cancer after previous treatment will be enrolled. Each participant will receive a single injection of 68Ga-SFB6-ZN01 and undergo one PET/CT scan within one week of joining the study. The main goals are: to see how safe the imaging agent is and whether it causes any side effects; to understand how the agent distributes in the body, and how much radiation exposure it gives; to determine how accurately 68Ga-SFB6-ZN01 PET/CT can detect cancerous lesions and correctly stage the disease, using biopsy results or long-term follow-up (≥6 months) as the reference standard; to explore whether the PET signal intensity (e.g., SUVmax) correlates with the expression of integrin αvβ6 in the tumor tissue. No therapeutic treatment is given in this study. Participation involves one imaging visit and follow-up contact. The results will help determine whether this new tracer should be developed further for cancer imaging.

Conditions

  • Neoplasms

Interventions

DRUG

68Ga-SFB6-ZN01

Single intravenous bolus injection of 68Ga-SFB6-ZN01 (target activity: 111-185 MBq) followed by whole-body PET/CT scan at 60 ± 10 minutes post-injection.

Sponsors & Collaborators

  • Zhongnan 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
2026-03-10
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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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 NCT07420036 on ClinicalTrials.gov