68Ga-SorB PET/CT Imaging in Patients With Solid Tumors

Sponsor
Peking University Third Hospital
Study ID
NCT07760012
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 68Ga-SorB PET/CT — DIAGNOSTIC_TEST
    Participants will receive a single intravenous administration of 68Ga-SorB (approximately 3.7 MBq/kg), followed by whole-body PET/CT imaging approximately 60 minutes after injection. The imaging findings will be compared with clinically indicated 18F-FDG PET/CT and reference standard findings to evaluate the safety, feasibility, biodistribution, tumor uptake, and exploratory diagnostic performance of 68Ga-SorB PET/CT.

Study Details

This prospective, single-center, open-label exploratory diagnostic study aims to evaluate the safety, feasibility, and diagnostic performance of the novel Sortilin-targeted PET tracer 68Ga-SorB in patients with solid tumors. Eligible participants with confirmed or suspected melanoma, hepatocellular carcinoma, lung cancer, pancreatic cancer, breast cancer, or ovarian cancer will undergo 68Ga-SorB PET/CT imaging. The imaging findings will be compared with standard-of-care 18F-FDG PET/CT, using pathology results and/or clinical follow-up as the reference standard. The primary objectives are to evaluate the safety and tolerability of 68Ga-SorB, assess imaging feasibility, and characterize tumor uptake using quantitative PET parameters, including SUVmax and tumor-to-background ratio (TBR). Secondary exploratory objectives include comparing lesion detection between 68Ga-SorB PET/CT and 18F-FDG PET/CT, assessing diagnostic sensitivity and specificity, evaluating imaging characteristics across different tumor types, and exploring the correlation between Sortilin expression and tracer uptake. This study will provide preliminary clinical evidence supporting the development of Sortilin-targeted molecular imaging and future theranostic applications.

Key Dates

First listed
Aug 12, 2026
Start date
Jul 24, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 68Ga-SorB PET/CT Imaging
    Participants with suspected or confirmed malignant tumors will receive a single intravenous administration of 68Ga-SorB followed by PET/CT imaging. Imaging findings will be compared with clinically indicated 18F-FDG PET/CT performed within the predefined time window. No therapeutic intervention will be administered as part of this study.

Primary Outcome Measure

Incidence of adverse events related to 68Ga-SorB PET/CT [ Time Frame: From tracer administration until completion of the imaging visit (approximately 24 hours). ]

Central Contacts

Find similar trials

Nationwide
Breast cancer trialsLiver cancer trialsLung cancer trialsOvarian cancer trialsPancreatic cancer trialsOncology trialsBreast oncology trialsWomen's health trialsGI oncology trialsHepatology trialsLung oncology trialsLung disease trialsGynecologic oncology trials

Related Studies