RecruitingNot Applicable

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

China50 participantsStarted 2026-07-24

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \- Adults aged 18 to 75 years. * Histologically confirmed or clinically suspected melanoma, hepatocellular carcinoma, lung cancer, breast cancer, pancreatic cancer, or ovarian cancer. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic, hepatic, renal, and coagulation function: * White blood cell count ≥ 4.0 × 10\^9/L or absolute neutrophil count ≥ 1.5 × 10\^9/L; * Platelet count ≥ 100 × 10\^9/L; * Hemoglobin ≥ 90 g/L; * PT or APTT ≤ 1.5 × upper limit of normal (ULN); * Total bilirubin ≤ 1.5 × ULN; * ALT and AST ≤ 2.5 × ULN (or ≤ 5 × ULN for participants with liver metastases); * ALP ≤ 2.5 × ULN (or ≤ 4.5 × ULN for participants with bone or liver metastases); * Blood urea nitrogen and serum creatinine ≤ 1.5 × ULN. * Normal cardiac function. * Estimated life expectancy of at least 12 weeks. * Willing and able to comply with study procedures and follow-up. * At least one measurable target lesion according to RECIST version 1.1. * Participants of childbearing potential agree to use effective contraception during the study and for 3 months after PET/CT imaging. * Clinically indicated to undergo 18F-FDG PET/CT for tumor evaluation. * Able to understand the study procedures and provide written informed consent. Exclusion Criteria: * Pregnant or breastfeeding women. * Severe dysfunction of major organs (including heart, liver, or kidney) that, in the investigator's judgment, would make participation inappropriate.…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of adverse events related to 68Ga-SorB PET/CT

Timeframe: From tracer administration until completion of the imaging visit (approximately 24 hours).

Successful completion of 68Ga-SorB PET/CT imaging

Timeframe: At completion of PET/CT imaging (approximately 60 minutes after tracer injection)

Tumor uptake of 68Ga-SorB measured by SUVmax

Timeframe: At PET/CT imaging (approximately 60 minutes after tracer injection)

Trial details

NCT IDNCT07760012

SponsorPeking University Third Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Meixin Zhao

86-10-82264936 zhaomeixin.student@sina.com

View on ClinicalTrials.gov More Melanoma (Skin Cancer) trials