MalignancyNCT06715839
Target-specific immunoPET Imaging of Digestive System Carcinoma
A study testing [68Ga]Ga-DOTA-H2D3, [18F]F-RESCA-RB14 and [68Ga]Ga-NOTA-T4 in people with Malignancy and Digestive Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
The aim of this study is to establish and optimize the target-specific PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignancy, Digestive Cancer, Digestive System Neoplasm
- What is being tested?
- [68Ga]Ga-DOTA-H2D3, [18F]F-RESCA-RB14 and [68Ga]Ga-NOTA-T4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2024to Sep 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years old and of either sex；
- Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging;
- Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
Who cannot join
- Pregnancy；
- Severe hepatic and renal insufficiency;
- History of serious surgery in the last month;
- Allergic to antibody or single-domain antibody radiopharmaceuticals.
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
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Weijun Wei, Ph.D. & M.D., 15000083153, wwei@shsmu.edu.cn
Shuxian An, Ph.D. & M.D., 17717453484, anshuxian@shsmu.edu.cn
About this study
Official title: Development and Clinical Translation of immunoPET Imaging Probes for Digestive System Carcinoma
The aim of this study is to establish and optimize the target-specific PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated.
Read the detailed description
Enrolled patients will undergo whole-body PET/CT scans at 1 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of above imaging agents in tumor and normal organs/tissues will be scored visually and quantitatively.
Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.
- Conditions
- Malignancy, Digestive Cancer, Digestive System Neoplasm, Digestive System Carcinoma, Digestive System Cancer, Liver Cancer
- Being tested
- [68Ga]Ga-DOTA-H2D3, [18F]F-RESCA-RB14, [68Ga]Ga-NOTA-T4, [18F]F-RESCA-T4, [68Ga]Ga-NOTA-G5
- Keywords
- human epidermal growth factor receptor 2 (HER2), Trophoblast cell surface antigen 2 (TROP2), Glypican-3 (GPC3), Glycoprotein A33 (gpA33), Nectin cell adhesion molecule-4 (Nectin-4)
- Medical subject headings
- Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Liver Neoplasms, Stomach Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-DOTA-H2D3Drug
Also called [68Ga]Ga-H2D3
Enrolled patients (especially those with gastric cancer) will receive 0.05-0.1 mCi/kg of a HER2-targeted probe ([68Ga]Ga-DOTA-H2D3). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-DOTA-H2D3 injection.
[18F]F-RESCA-RB14Drug
Also called [18F]F-RB14
Enrolled patients (especially those with gastric cancer) will receive 0.05-0.1 mCi/kg of a HER2-targeted probe ([18F]F-RESCA-RB14). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-RB14 injection.
[68Ga]Ga-NOTA-T4Drug
Also called [68Ga]Ga-T4
Enrolled patients (especially those with gastric cancer/pancreatic cancer) will receive 0.05-0.1 mCi/kg of a Trop2-targeted probe ([68Ga]Ga-NOTA-T4). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-T4 injection.
[18F]F-RESCA-T4Drug
Also called [18F]F-T4
Enrolled patients (especially those with gastric cancer/pancreatic cancer) will receive 0.05-0.1 mCi/kg of a Trop2-targeted probe ([18F]F-RESCA-T4). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-T4 injection.
[68Ga]Ga-NOTA-G5Drug
Also called [68Ga]Ga-G5
Enrolled patients (especially those with hepatocellular carcinoma) will receive 0.05-0.1 mCi/kg of a GPC3-targeted probe ([68Ga]Ga-NOTA-G5). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-G5 injection.
[18F]F-RESCA-G5Drug
Also called [18F]F-G5
Enrolled patients (especially those with hepatocellular carcinoma) will receive 0.05-0.1 mCi/kg of a GPC3-targeted probe ([18F]F-RESCA-G5). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-G5 injection.
[68Ga]Ga-NOTA-WWH347Drug
Also called [68Ga]Ga-WWH347
Enrolled patients (especially those with colorectal cancer) will receive 0.05-0.1 mCi/kg of a GPA33-targeted probe ([68Ga]Ga-NOTA-WWH347). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-WWH347 injection.
[18F]F-RESCA-WWH347Drug
Also called [18F]F-WWH347
Enrolled patients (especially those with colorectal cancer) will receive 0.05-0.1 mCi/kg of a GPA33-targeted probe ([18F]F-RESCA-WWH347). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-WWH347 injection.
[68Ga]Ga-NOTA-RND20Drug
Also called [68Ga]Ga-RND20
Enrolled patients will receive 0.05-0.1 mCi/kg of a Nectin-4-targeted probe ([68Ga]Ga-NOTA-RND20). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-RND20 injection.
[18F]F-RESCA-RND20Drug
Also called [18F]F-RND20
Enrolled patients will receive 0.05-0.1 mCi/kg of a Nectin-4-targeted probe ([18F]F-RESCA-RND20). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-RND20 injection.
| Study group | Role | What they receive |
|---|---|---|
| ImmunoPET imaging in patients with digestive system carcinoma | Experimental | Enrolled patients will undergo a targeted-specific immunoPET/CT scanning. Receives: Drug: [68Ga]Ga-DOTA-H2D3; Drug: [18F]F-RESCA-RB14; Drug: [68Ga]Ga-NOTA-T4; Drug: [18F]F-RESCA-T4; Drug: [68Ga]Ga-NOTA-G5; Drug: [18F]F-RESCA-G5; Drug: [68Ga]Ga-NOTA-WWH347; Drug: [18F]F-RESCA-WWH347; Drug: [68Ga]Ga-NOTA-RND20; Drug: [18F]F-RESCA-RND20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodistribution
Measurement of the overall biodistribution of above tracers in normal tissues and organs.
Measured: 1 day from injection of the tracers
Standardized uptake value (SUV)
Standardized uptake value (SUV) of above tracers in the included subjects' primary and/or metastatic lesions.
Measured: 1 day from injection of the tracers
Radiation dosimetry
Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs, tumor(s), and whole body (Sv/MBq). Dynamic imaging within one hour will be acquired for the purpose.
Measured: 1 day from injection of the tracers
Diagnostic value in patients with digestive system malignancy
Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics and, more importantly, the clinical value of these target-specific tracers in patients with malignancies of the digestive system.
Measured: 30 days
The correlation between the expression of specific target and tracer uptake value
The Standardized uptake value (SUV) will be calculated, and the correlation between pathological results and tumor uptake of these tracers will be analyzed.
Measured: 60 days
Secondary outcomes (2)
Predictive value of these tracers in the course of combined immunotherapies and targeted therapies
Baseline and follow-up immunoPET imaging in combined immunotherapies and targeted therapies (four to eight cycles) will be investigated in this setting to determine the value of the immunoPET imaging in predicting or evaluating treatment responses.
Measured: 3-6 months
Target-specific PET/CT in changing clinical decision-making for patients with digestive system malignancy
After analyzing the imaging parameters and diagnostic/predictive value of these target-specific tracers, we will also investigate how clinical use of these tracers changes clinical decision-making for patients with malignant tumors of the digestive system. Joint efforts from nuclear medicine physicians, surgeons, oncologists, and pathologists will draw solid conclusions from the imaging and clinical information.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start4 Dec 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weijun Wei, Study chair, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715839
- Sponsor's protocol ID
- KY2024-107-C
- Status last verified
- Dec 2025
- First submitted
- 29 Nov 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Translation of immunoPET Imaging Probes for Digestive System Carcinoma
- ClinicalTrials.gov ID
- NCT06715839
- Acronym / sponsor ID
- KY2024-107-C
- Conditions
- Malignancy, Digestive Cancer, Digestive System Neoplasm, Digestive System Carcinoma, Digestive System Cancer, Liver Cancer
- Keywords
- human epidermal growth factor receptor 2 (HER2), Trophoblast cell surface antigen 2 (TROP2), Glypican-3 (GPC3), Glycoprotein A33 (gpA33), Nectin cell adhesion molecule-4 (Nectin-4)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 Dec 2024 (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.
The aim of this study is to establish and optimize the target-specific PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated.
Detailed description
Enrolled patients will undergo whole-body PET/CT scans at 1 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of above imaging agents in tumor and normal organs/tissues will be scored visually and quantitatively.
Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ImmunoPET imaging in patients with digestive system carcinoma | Experimental | Drug: [68Ga]Ga-DOTA-H2D3, Drug: [18F]F-RESCA-RB14, Drug: [68Ga]Ga-NOTA-T4, Drug: [18F]F-RESCA-T4, Drug: [68Ga]Ga-NOTA-G5, Drug: [18F]F-RESCA-G5, Drug: [68Ga]Ga-NOTA-WWH347, Drug: [18F]F-RESCA-WWH347, Drug: [68Ga]Ga-NOTA-RND20, Drug: [18F]F-RESCA-RND20Enrolled patients will undergo a targeted-specific immunoPET/CT scanning. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-75 years old and of either sex；
- Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging;
- Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
Key exclusion criteria (4 listed)
- Pregnancy；
- Severe hepatic and renal insufficiency;
- History of serious surgery in the last month;
- Allergic to antibody or single-domain antibody radiopharmaceuticals.
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]Ga-DOTA-H2D3Also: [68Ga]Ga-H2D3Enrolled patients (especially those with gastric cancer) will receive 0.05-0.1 mCi/kg of a HER2-targeted probe ([68Ga]Ga-DOTA-H2D3). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-DOTA-H2D3 injection. | Drug | ImmunoPET imaging in patients with digestive system carcinoma |
| [18F]F-RESCA-RB14Also: [18F]F-RB14Enrolled patients (especially those with gastric cancer) will receive 0.05-0.1 mCi/kg of a HER2-targeted probe ([18F]F-RESCA-RB14). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-RB14 injection. | Drug | ImmunoPET imaging in patients with digestive system carcinoma |
| [68Ga]Ga-NOTA-T4Also: [68Ga]Ga-T4Enrolled patients (especially those with gastric cancer/pancreatic cancer) will receive 0.05-0.1 mCi/kg of a Trop2-targeted probe ([68Ga]Ga-NOTA-T4). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-T4 injection. | Drug | ImmunoPET imaging in patients with digestive system carcinoma |
| [18F]F-RESCA-T4Also: [18F]F-T4Enrolled patients (especially those with gastric cancer/pancreatic cancer) will receive 0.05-0.1 mCi/kg of a Trop2-targeted probe ([18F]F-RESCA-T4). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-T4 injection. | Drug | ImmunoPET imaging in patients with digestive system carcinoma |
| [68Ga]Ga-NOTA-G5Also: [68Ga]Ga-G5Enrolled patients (especially those with hepatocellular carcinoma) will receive 0.05-0.1 mCi/kg of a GPC3-targeted probe ([68Ga]Ga-NOTA-G5). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-G5 injection. | Drug | ImmunoPET imaging in patients with digestive system carcinoma |
| [18F]F-RESCA-G5Also: [18F]F-G5Enrolled patients (especially those with hepatocellular carcinoma) will receive 0.05-0.1 mCi/kg of a GPC3-targeted probe ([18F]F-RESCA-G5). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-G5 injection. | Drug | ImmunoPET imaging in patients with digestive system carcinoma |
| [68Ga]Ga-NOTA-WWH347Also: [68Ga]Ga-WWH347Enrolled patients (especially those with colorectal cancer) will receive 0.05-0.1 mCi/kg of a GPA33-targeted probe ([68Ga]Ga-NOTA-WWH347). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-WWH347 injection. | Drug | ImmunoPET imaging in patients with digestive system carcinoma |
| [18F]F-RESCA-WWH347Also: [18F]F-WWH347Enrolled patients (especially those with colorectal cancer) will receive 0.05-0.1 mCi/kg of a GPA33-targeted probe ([18F]F-RESCA-WWH347). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-WWH347 injection. | Drug | ImmunoPET imaging in patients with digestive system carcinoma |
| [68Ga]Ga-NOTA-RND20Also: [68Ga]Ga-RND20Enrolled patients will receive 0.05-0.1 mCi/kg of a Nectin-4-targeted probe ([68Ga]Ga-NOTA-RND20). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-RND20 injection. | Drug | ImmunoPET imaging in patients with digestive system carcinoma |
| [18F]F-RESCA-RND20Also: [18F]F-RND20Enrolled patients will receive 0.05-0.1 mCi/kg of a Nectin-4-targeted probe ([18F]F-RESCA-RND20). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-RND20 injection. | Drug | ImmunoPET imaging in patients with digestive system carcinoma |
Primary outcome
Biodistribution
Time frame: 1 day from injection of the tracers
Measurement of the overall biodistribution of above tracers in normal tissues and organs.
Standardized uptake value (SUV)
Time frame: 1 day from injection of the tracers
Standardized uptake value (SUV) of above tracers in the included subjects' primary and/or metastatic lesions.
Radiation dosimetry
Time frame: 1 day from injection of the tracers
Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs, tumor(s), and whole body (Sv/MBq). Dynamic imaging within one hour will be acquired for the purpose.
Diagnostic value in patients with digestive system malignancy
Time frame: 30 days
Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics and, more importantly, the clinical value of these target-specific tracers in patients with malignancies of the digestive system.
The correlation between the expression of specific target and tracer uptake value
Time frame: 60 days
The Standardized uptake value (SUV) will be calculated, and the correlation between pathological results and tumor uptake of these tracers will be analyzed.
2 secondary outcomes
Predictive value of these tracers in the course of combined immunotherapies and targeted therapies
Time frame: 3-6 months
Target-specific PET/CT in changing clinical decision-making for patients with digestive system malignancy
Time frame: 3-6 months
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 31 Dec 2025.
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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.
Weijun Wei study chair
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
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]Ga-DOTA-H2D3, [18F]F-RESCA-RB14 and [68Ga]Ga-NOTA-T4 in people with Malignancy and Digestive Cancer, run by RenJi 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 3 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 31 Dec 2025. 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 Weijun Wei, Ph.D. & M.D. (15000083153, wwei@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution (time frame: 1 day from injection of the tracers). The study lists 5 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 31 Dec 2025.