68Ga-SorB PET/CT Imaging in Patients With Solid Tumors (SORB-PET)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Meixin Zhao
- 電話番号：86-10-82264936
- メール：zhaomeixin.student@sina.com
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100191
- 募集
- Peking University Third Hospital
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コンタクト：
- Meixin Zhao
- 電話番号：86-10-82264936
- メール：zhaomeixin.student@sina.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of adverse events related to 68Ga-SorB PET/CT
時間枠：From tracer administration until completion of the imaging visit (approximately 24 hours).
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Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) related to administration of 68Ga-SorB, graded according to CTCAE.
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From tracer administration until completion of the imaging visit (approximately 24 hours).
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Successful completion of 68Ga-SorB PET/CT imaging
時間枠：At completion of PET/CT imaging (approximately 60 minutes after tracer injection)
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Proportion of participants completing 68Ga-SorB PET/CT with evaluable image quality.
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At completion of PET/CT imaging (approximately 60 minutes after tracer injection)
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Tumor uptake of 68Ga-SorB measured by SUVmax
時間枠：At PET/CT imaging (approximately 60 minutes after tracer injection)
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Maximum standardized uptake value (SUVmax) of target lesions measured on 68Ga-SorB PET/CT.
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At PET/CT imaging (approximately 60 minutes after tracer injection)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Lesion detection rate on 68Ga-SorB PET/CT
時間枠：At completion of 68Ga-SorB PET/CT imaging, with reference-standard adjudication up to approximately 3 months after imaging.
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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.
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At completion of 68Ga-SorB PET/CT imaging, with reference-standard adjudication up to approximately 3 months after imaging.
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Cohen's kappa coefficient for lesion detection agreement between 68Ga-SorB PET/CT and 18F-FDG PET/CT
時間枠：Within 2 weeks after completion of both PET/CT examinations.
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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.
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Diagnostic sensitivity of 68Ga-SorB PET/CT for lesion detection
時間枠：Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.
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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.
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Tumor SUVmax on 68Ga-SorB PET/CT by tumor type
時間枠：At completion of 68Ga-SorB PET/CT imaging, approximately 60 minutes after tracer administration.
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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.
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Correlation between Sortilin expression H-score and 68Ga-SorB PET/CT uptake parameters
時間枠：Within approximately 3 months after PET/CT imaging, following completion of pathological assessment.
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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.
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Percentage of participants with a change in clinical diagnosis or tumor staging after 68Ga-SorB PET/CT
時間枠：Within approximately 3 months after 68Ga-SorB PET/CT imaging.
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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.
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Diagnostic specificity of 68Ga-SorB PET/CT for lesion detection
時間枠：Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.
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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.
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Diagnostic accuracy of 68Ga-SorB PET/CT for lesion detection
時間枠：Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.
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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.
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Positive predictive value of 68Ga-SorB PET/CT for lesion detection
時間枠：Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.
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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.
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Negative predictive value of 68Ga-SorB PET/CT for lesion detection
時間枠：Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.
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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.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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追加の関連 MeSH 用語
その他の研究ID番号
- IRB00006761-M20260651
個々の参加者データ (IPD) の計画
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IPD プランの説明
医薬品およびデバイス情報、研究文書
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米国FDA規制機器製品の研究
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