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

NCT07760012 | Recruiting

• 1 other identifier: IRB00006761-M20260651
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma (Skin Cancer); Hepatocellular Carcinoma; Lung Cancer; Breast Cancer; Pancreatic Cancer; Ovarian Cancer

Keywords

Sortilin; 68Ga-SorB; PET/CT; Molecular Imaging; Diagnostic Imaging; Positron Emission Tomography; Radiotracer; Oncology

Outcome Measures

Primary Outcomes (3)

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

  Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) related to administration of 68Ga-SorB, graded according to CTCAE.

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

• Successful completion of 68Ga-SorB PET/CT imaging

  Proportion of participants completing 68Ga-SorB PET/CT with evaluable image quality.

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

• Tumor uptake of 68Ga-SorB measured by SUVmax

  Maximum standardized uptake value (SUVmax) of target lesions measured on 68Ga-SorB PET/CT.

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

Secondary Outcomes (10)

• Lesion detection rate on 68Ga-SorB PET/CT

  At completion of 68Ga-SorB PET/CT imaging, with reference-standard adjudication up to approximately 3 months after imaging.

• Cohen's kappa coefficient for lesion detection agreement between 68Ga-SorB PET/CT and 18F-FDG PET/CT

  Within 2 weeks after completion of both PET/CT examinations.

• Diagnostic sensitivity of 68Ga-SorB PET/CT for lesion detection

  Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.

• Tumor SUVmax on 68Ga-SorB PET/CT by tumor type

  At completion of 68Ga-SorB PET/CT imaging, approximately 60 minutes after tracer administration.

• Correlation between Sortilin expression H-score and 68Ga-SorB PET/CT uptake parameters

  Within approximately 3 months after PET/CT imaging, following completion of pathological assessment.

Study Arms (1)

68Ga-SorB PET/CT Imaging

EXPERIMENTAL

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.

Diagnostic Test: 68Ga-SorB PET/CT

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.

68Ga-SorB PET/CT Imaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Melanoma; Carcinoma, Hepatocellular; Lung Neoplasms; Breast Neoplasms; Pancreatic Neoplasms; Ovarian Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders

Central Study Contacts

Meixin Zhao

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: PET/CT images will be independently interpreted by two experienced nuclear medicine physicians who are blinded to pathology results, clinical follow-up findings, and final clinical diagnosis. Any discrepancies will be resolved by a third independent nuclear medicine physician.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-center, open-label exploratory diagnostic imaging study. All enrolled participants will undergo one 68Ga-SorB PET/CT examination in addition to clinically indicated 18F-FDG PET/CT. Diagnostic performance will be evaluated using paired within-subject comparison. No randomization or therapeutic intervention will be performed.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 12, 2026
• Study Start: July 24, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)