68Ga-SorB PET/CT imaging for solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, open-label exploratory imaging study to evaluate the safety, feasibility, and diagnostic performance of the Sortilin-targeted PET tracer 68Ga-SorB in patients with solid tumors. Participants will undergo 68Ga-SorB PET/CT and, when available, standard-of-care 18F-FDG PET/CT, with pathology and/or clinical follow-up used as the reference standard. Primary goals include safety and tolerability, imaging feasibility, and characterization of tumor uptake using SUVmax and tumor-to-background ratio. Secondary goals compare 68Ga-SorB to 18F-FDG in lesion detection and estimate diagnostic sensitivity and specificity. The study leverages Sortilin’s tumor-associated expression as a target for improved oncologic imaging.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18 or older.
* Histologically confirmed or clinically suspected melanoma, hepatocellular carcinoma, lung cancer, breast cancer, pancreatic cancer, ovarian cancer, or cholangiocarcinoma.
* 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.
* Inability to tolerate PET/CT imaging or complete study follow-up.
* Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Where it's running

• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Meixin Zhao
• Email: zhaomeixin.student@sina.com
• Phone: 86-10-82264936

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.