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

9 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

50

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Recrutamento
        • Peking University Third Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Diagnóstico
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Teste de diagnostico: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Incidence of adverse events related to 68Ga-SorB PET/CT
Prazo: 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
Prazo: 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
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Lesion detection rate on 68Ga-SorB PET/CT
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Peking University Third Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

24 de julho de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2027

Conclusão do estudo (Estimado)

31 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

29 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de agosto de 2026

Primeira postagem (Real)

12 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de agosto de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IRB00006761-M20260651

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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