Melanoma (Skin Cancer)SORB-PETNCT07760012
68Ga-SorB PET/CT Imaging in Patients With Solid Tumors
A study testing 68Ga-SorB PET/CT in people with Melanoma (Skin Cancer) and Hepatocellular Carcinoma, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin Cancer), Hepatocellular Carcinoma, Lung Cancer
- What is being tested?
- 68Ga-SorB PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 or older.
- Histologically confirmed or clinically suspected melanoma, hepatocellular carcinoma, lung cancer, breast cancer, pancreatic cancer, ovarian cancer, or cholangiocarcinoma.
- 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;
Show all 19Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Meixin Zhao, 86-10-82264936, zhaomeixin.student@sina.com
About this study
Official title: 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, ovarian cancer, or cholangiocarcinoma 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.
Read the detailed description
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, ovarian cancer, and cholangiocarcinoma, 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, ovarian cancer, or cholangiocarcinoma 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.
- Conditions
- Melanoma (Skin Cancer), Hepatocellular Carcinoma, Lung Cancer, Breast Cancer, Pancreatic Cancer, Ovarian Cancer
- Being tested
- 68Ga-SorB PET/CT
- Keywords
- Sortilin, 68Ga-SorB, PET/CT, Molecular Imaging, Diagnostic Imaging, Positron Emission Tomography, Radiotracer, Oncology
- Medical subject headings
- Melanoma, Carcinoma, Hepatocellular, Lung Neoplasms, Breast Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Cholangiocarcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-SorB PET/CTDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 68Ga-SorB PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At PET/CT imaging (approximately 60 minutes after tracer injection)
Secondary outcomes (10)
Lesion detection rate on 68Ga-SorB PET/CT
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.
Measured: 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
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.
Measured: Within 2 weeks after completion of both PET/CT examinations.
Diagnostic sensitivity of 68Ga-SorB PET/CT for lesion detection
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.
Measured: 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
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, ovarian cancer, and cholangiocarcinoma, as applicable. SUVmax will be measured on fused PET/CT images using ROI/VOI delineation.
Unit of Measure: Unitless standardized uptake value.
Measured: 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
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.
Measured: 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
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.
Measured: Within approximately 3 months after 68Ga-SorB PET/CT imaging.
Diagnostic specificity of 68Ga-SorB PET/CT for lesion detection
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start13 Aug 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760012
- Sponsor's protocol ID
- IRB00006761-M20260651
- Acronym
- SORB-PET
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because of participant privacy considerations and institutional data-sharing policies.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Open-Label Exploratory Study of 68Ga-SorB PET/CT Imaging for the Diagnosis of Sortilin-Positive Solid Tumors
- ClinicalTrials.gov ID
- NCT07760012
- Acronym / sponsor ID
- SORB-PET / IRB00006761-M20260651
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, ovarian cancer, or cholangiocarcinoma 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.
Detailed description
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, ovarian cancer, and cholangiocarcinoma, 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, ovarian cancer, or cholangiocarcinoma 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 68Ga-SorB PET/CT Imaging | Experimental | Diagnostic Test: 68Ga-SorB PET/CTParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Adults aged 18 or older.
- Histologically confirmed or clinically suspected melanoma, hepatocellular carcinoma, lung cancer, breast cancer, pancreatic cancer, ovarian cancer, or cholangiocarcinoma.
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-SorB PET/CTParticipants 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. | Diagnostic test | 68Ga-SorB PET/CT Imaging |
Primary outcome
Incidence of adverse events related to 68Ga-SorB PET/CT
Time frame: 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.
Successful completion of 68Ga-SorB PET/CT imaging
Time frame: At completion of PET/CT imaging (approximately 60 minutes after tracer injection)
Proportion of participants completing 68Ga-SorB PET/CT with evaluable image quality.
Tumor uptake of 68Ga-SorB measured by SUVmax
Time frame: At PET/CT imaging (approximately 60 minutes after tracer injection)
Maximum standardized uptake value (SUVmax) of target lesions measured on 68Ga-SorB PET/CT.
10 secondary outcomes
Lesion detection rate on 68Ga-SorB PET/CT
Time frame: 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
Time frame: Within 2 weeks after completion of both PET/CT examinations.
Diagnostic sensitivity of 68Ga-SorB PET/CT for lesion detection
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Within approximately 3 months after 68Ga-SorB PET/CT imaging.
Diagnostic specificity of 68Ga-SorB PET/CT for lesion detection
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Within approximately 3 months after PET/CT imaging, following completion of pathology assessment, clinical diagnosis, and/or imaging follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because of participant privacy considerations and institutional data-sharing policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-SorB PET/CT in people with Melanoma (Skin Cancer) and Hepatocellular Carcinoma, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meixin Zhao (86-10-82264936, zhaomeixin.student@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events related to 68Ga-SorB PET/CT (time frame: From tracer administration until completion of the imaging visit (approximately 24 hours).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.