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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Meixin Zhao
- 전화번호: 86-10-82264936
- 이메일: zhaomeixin.student@sina.com
연구 장소
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, 중국, 100191
- 모병
- Peking University Third Hospital
-
연락하다:
- Meixin Zhao
- 전화번호: 86-10-82264936
- 이메일: zhaomeixin.student@sina.com
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of adverse events related to 68Ga-SorB PET/CT
기간: 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
기간: 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
기간: 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)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Lesion detection rate on 68Ga-SorB PET/CT
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 비뇨생식기 질환
- 생식기 질환
- 내분비계 질환
- 비뇨생식기 신생물
- 부위별 신생물
- 여성 비뇨 생식기 질환
- 여성 비뇨 생식기 질환 및 임신 합병증
- 호흡기 질환
- 조직학적 유형에 따른 신생물
- 소화계 신생물
- 소화기계 질환
- 생식기 질환, 여성
- 폐 질환
- 내분비샘 신생물
- 췌장 질환
- 간 질환
- 신생물, 선상 및 상피
- 선암종
- 간 신생물
- 호흡기 신생물
- 흉부 신생물
- 난소 질환
- 부속기 질환
- 생식기 신생물, 여성
- 생식선 장애
- 피부병
- 유방 질환
- 암종
- 신경외배엽 종양
- 신생물, 생식 세포 및 배아
- 신생물, 신경 조직
- 신경내분비종양
- 모반과 흑색종
- 피부 신생물
- 피부 및 결합 조직 질환
- 신생물
- 암종, 간세포
- 폐 신생물
- 난소 신생물
- 유방 신생물
- 췌장 신생물
- 흑색종
기타 연구 ID 번호
기타 연구 ID 번호
- IRB00006761-M20260651
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .