此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年8月9日 更新者：Peking University Third Hospital

A Prospective, Single-Center, Open-Label Exploratory Study of 68Ga-SorB PET/CT Imaging for the Diagnosis of Sortilin-Positive Solid Tumors

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Background Sortilin is a type I transmembrane receptor belonging to the VPS10 receptor family. It is highly expressed in a variety of malignancies, including melanoma, hepatocellular carcinoma, lung cancer, pancreatic cancer, breast cancer, and ovarian cancer, while showing relatively low expression in most normal tissues. Due to its tumor-specific expression pattern and efficient receptor-mediated internalization, Sortilin has emerged as a promising molecular target for cancer imaging and targeted theranostic applications.

Although ^18F-FDG PET/CT is widely used for oncologic imaging, its diagnostic performance may be limited by nonspecific uptake in inflammatory lesions, resulting in false-positive findings. Therefore, a more tumor-specific PET tracer may improve lesion detection and diagnostic accuracy.

Study Design This is a prospective, single-center, open-label, exploratory diagnostic imaging study designed to evaluate the clinical performance of the novel Sortilin-targeted PET radiotracer ^68Ga-SorB. Approximately 40-50 adult patients with confirmed or suspected melanoma, hepatocellular carcinoma, lung cancer, pancreatic cancer, breast cancer, pancreatic cancer, or ovarian cancer will be enrolled. All participants will undergo ^68Ga-SorB PET/CT imaging according to the study protocol. Standard-of-care ^18F-FDG PET/CT performed within the predefined time window will be used as the comparator whenever available.

Histopathological findings and/or clinical and imaging follow-up will serve as the reference standard for evaluating diagnostic performance.

Study Objectives The primary objectives are to evaluate the safety and tolerability of ^68Ga-SorB, assess imaging feasibility, and characterize tracer biodistribution and tumor uptake using quantitative PET parameters, including SUVmax and tumor-to-background ratio (TBR).

Secondary exploratory objectives include comparison of lesion detection between ^68Ga-SorB PET/CT and ^18F-FDG PET/CT, estimation of diagnostic sensitivity, specificity, and accuracy, evaluation of tracer uptake across different tumor types, assessment of the association between Sortilin expression and imaging parameters, and exploration of the potential clinical value of ^68Ga-SorB PET/CT in tumor diagnosis and staging.

Study Significance This exploratory clinical study is expected to generate preliminary evidence regarding the safety, feasibility, and diagnostic performance of ^68Ga-SorB PET/CT in patients with solid tumors. The results may support further multicenter validation studies and facilitate the clinical development of Sortilin-targeted molecular imaging and future theranostic strategies.

研究类型

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100191

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.
  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
诊断测试：68Ga-SorB PET/CT
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of adverse events related to 68Ga-SorB PET/CT
大体时间：From tracer administration until completion of the imaging visit (approximately 24 hours).
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
大体时间：At completion of PET/CT imaging (approximately 60 minutes after tracer injection)
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
大体时间：At PET/CT imaging (approximately 60 minutes after tracer injection)
Maximum standardized uptake value (SUVmax) of target lesions measured on 68Ga-SorB PET/CT.
At PET/CT imaging (approximately 60 minutes after tracer injection)

次要结果测量

结果测量
措施说明
大体时间
Lesion detection rate on 68Ga-SorB PET/CT
大体时间：At completion of 68Ga-SorB PET/CT imaging, with reference-standard adjudication up to approximately 3 months after imaging.
Detection rate of reference standard-confirmed primary and metastatic tumor lesions visually identified on 68Ga-SorB PET/CT. Lesion detection will be assessed by lesion-based visual interpretation of 68Ga-SorB PET/CT images by nuclear medicine physicians. The detection rate will be calculated as the percentage of reference standard-confirmed lesions detected on 68Ga-SorB PET/CT. The reference standard will include pathology, clinical diagnosis, and/or imaging follow-up, as applicable.
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
大体时间：Within 2 weeks after completion of both PET/CT examinations.

Agreement in lesion detection between 68Ga-SorB PET/CT and clinically indicated 18F-FDG PET/CT. For each evaluable lesion, detection status will be recorded as detected or not detected on each PET/CT modality based on lesion-based visual image interpretation by nuclear medicine physicians. Agreement between the two PET/CT modalities will be assessed using Cohen's kappa coefficient with 95% confidence interval.

Unit of Measure: Cohen's kappa coefficient, unitless.
Within 2 weeks after completion of both PET/CT examinations.
Diagnostic sensitivity of 68Ga-SorB PET/CT for lesion detection
大体时间：Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.

Diagnostic sensitivity of 68Ga-SorB PET/CT for lesion detection will be calculated using pathology, clinical diagnosis, and/or imaging follow-up as the reference standard. Lesion detection will be assessed by lesion-based visual interpretation of 68Ga-SorB PET/CT images by nuclear medicine physicians.

Unit of Measure: Percentage.
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
大体时间：At completion of 68Ga-SorB PET/CT imaging, approximately 60 minutes after tracer administration.

Maximum standardized uptake value of tumor lesions on 68Ga-SorB PET/CT across different tumor types, including malignant melanoma, hepatocellular carcinoma, lung cancer, breast cancer, pancreatic cancer, and ovarian cancer, as applicable. SUVmax will be measured on fused PET/CT images using ROI/VOI delineation.

Unit of Measure: Unitless standardized uptake value.
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
大体时间：Within approximately 3 months after PET/CT imaging, following completion of pathological assessment.

Correlation between Sortilin expression in pathological tumor specimens and quantitative 68Ga-SorB PET/CT uptake parameters, including SUVmax and tumor-to-background ratio. For participants with available tissue samples, Sortilin expression will be measured by immunohistochemistry and reported as an H-score. SUVmax and tumor-to-background ratio will be measured on fused PET/CT images using ROI/VOI delineation. Correlation will be assessed using Pearson correlation analysis or Spearman rank correlation analysis, as appropriate.

Unit of Measure: Correlation coefficient, unitless. Underlying Variable Units: Sortilin H-score, score range 0-300; SUVmax, unitless standardized uptake value; tumor-to-background ratio, unitless ratio.
Within approximately 3 months after PET/CT imaging, following completion of pathological assessment.
Percentage of participants with a change in clinical diagnosis or tumor staging after 68Ga-SorB PET/CT
大体时间：Within approximately 3 months after 68Ga-SorB PET/CT imaging.

Percentage of participants whose clinical diagnosis or tumor staging changes after review of 68Ga-SorB PET/CT findings compared with the pre-PET/CT assessment based on standard imaging and clinical information. Changes in clinical diagnosis or tumor stage will be determined by investigator review of available clinical, imaging, pathological, and follow-up information.

Unit of Measure: Percentage of participants.
Within approximately 3 months after 68Ga-SorB PET/CT imaging.
Diagnostic specificity of 68Ga-SorB PET/CT for lesion detection
大体时间：Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.

Diagnostic specificity of 68Ga-SorB PET/CT for lesion detection will be calculated using pathology, clinical diagnosis, and/or imaging follow-up as the reference standard. Lesion detection will be assessed by lesion-based visual interpretation of 68Ga-SorB PET/CT images by nuclear medicine physicians.

Unit of Measure: Percentage.
Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.
Diagnostic accuracy of 68Ga-SorB PET/CT for lesion detection
大体时间：Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.

Diagnostic accuracy of 68Ga-SorB PET/CT for lesion detection will be calculated using pathology, clinical diagnosis, and/or imaging follow-up as the reference standard. Lesion detection will be assessed by lesion-based visual interpretation of 68Ga-SorB PET/CT images by nuclear medicine physicians.

Unit of Measure: Percentage.
Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.
Positive predictive value of 68Ga-SorB PET/CT for lesion detection
大体时间：Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.

Positive predictive value of 68Ga-SorB PET/CT for lesion detection will be calculated using pathology, clinical diagnosis, and/or imaging follow-up as the reference standard. Lesion detection will be assessed by lesion-based visual interpretation of 68Ga-SorB PET/CT images by nuclear medicine physicians.

Unit of Measure: Percentage.
Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.
Negative predictive value of 68Ga-SorB PET/CT for lesion detection
大体时间：Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.

Negative predictive value of 68Ga-SorB PET/CT for lesion detection will be calculated using pathology, clinical diagnosis, and/or imaging follow-up as the reference standard. Lesion detection will be assessed by lesion-based visual interpretation of 68Ga-SorB PET/CT images by nuclear medicine physicians.

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Peking University Third Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月24日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年7月29日

首先提交符合 QC 标准的

2026年8月9日

首次发布 (实际的)

2026年8月12日

研究记录更新

最后更新发布 (实际的)

2026年8月12日

上次提交的符合 QC 标准的更新

2026年8月9日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB00006761-M20260651

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be made publicly available because of participant privacy considerations and institutional data-sharing policies.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅