Solid TumorPhase 2/3NCT06851663
Trop2-targeted immunoPET Imaging of Solid Tumors
A Phase 2/3 study testing [68Ga]Ga-NOTA-T4, [68Ga]Ga-NOTA-RT4 and [18F]F-RESCA-T4 in people with Solid Tumor and Solid Carcinoma, run by RenJi Hospital at 1 site in China.
Trial summary
This study aims to establish and optimize the trophoblast cell surface antigen 2 (Trop2)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Solid Carcinoma, Uroepithelial Carcinoma
- What is being tested?
- [68Ga]Ga-NOTA-T4, [68Ga]Ga-NOTA-RT4 and [18F]F-RESCA-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
- 23 Dec 2024to Dec 2027
- Phase
- Phase 2/3
- 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 year-old and of either sex
- Histologically confirmed diagnosis of solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) or suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) by diagnostic imaging;
- Capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (ICF) and this protocol.
Who cannot join
- Pregnancy；
- Severe hepatic and renal insufficiency;
- Allergic to 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, 200127
Weijun Wei, 15000083153, wwei@shsmu.edu.cn
Shuxian An, 17717453484, anshuxian@shsmu.edu.cn
About this study
This study aims to establish and optimize the trophoblast cell surface antigen 2 (Trop2)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) will be evaluated.
Read the detailed description
Histologically confirmed solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer), or patients with suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) indicated by conventional diagnostic imaging will be included. Patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation.For patients with prostate cancer or suspected prostate cancer, head-to-head comparisons with PSMA PET are still needed.
Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.05-0.1 mCi/kg). The uptake of imaging tracers in tumors 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 assess the diagnostic efficacy. The correlation between lesion uptake and Trop2 expression level determined by immunohistochemistry staining will be further analyzed. The primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18F-FDG PET/CT.
- Conditions
- Solid Tumor, Solid Carcinoma, Uroepithelial Carcinoma, Bladder Cancer, Prostate Cancer, Lung Cancer
- Being tested
- [68Ga]Ga-NOTA-T4, [68Ga]Ga-NOTA-RT4, [18F]F-RESCA-T4, [18F]F-RESCA-RT4
- Keywords
- Trophoblast cell surface antigen 2 (Trop2), ImmunoPET, Solid Tumor
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Nasopharyngeal Neoplasms, Liver Neoplasms, Cholangiocarcinoma, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-NOTA-T4Drug
Also called [68Ga]T4
Enrolled patients will receive 0.05-0.1 mCi/kg of [68Ga]Ga-NOTA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-T4 injection.
[68Ga]Ga-NOTA-RT4Drug
Also called [68Ga]RT4
Enrolled patients will receive 0.05-0.1 mCi/kg of [68Ga]Ga-NOTA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-RT4 injection.
[18F]F-RESCA-T4Drug
Also called [18F]T4
Enrolled patients will receive 0.05-0.1 mCi/kg of [18F]F-RESCA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-T4 injection.
[18F]F-RESCA-RT4Drug
Also called [18F]RT4
Enrolled patients will receive 0.05-0.1 mCi/kg of [18F]F-RESCA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-RT4 injection.
| Study group | Role | What they receive |
|---|---|---|
| Trop2-targeted immunoPET imaging | Experimental | Enrolled patients will undergo a Trop2-targeted immunoPET/CT scanning. Receives: Drug: [68Ga]Ga-NOTA-T4; Drug: [68Ga]Ga-NOTA-RT4; Drug: [18F]F-RESCA-T4; Drug: [18F]F-RESCA-RT4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodistribution-Standardized uptake value (SUV) of normal tissues and organs.
Measurement of the overall biodistribution of the above tracers in normal tissues and organs (bladder (after voiding), background (pelvic fat), blood, brain, salivary and lacrimal glands, lung, liver, spleen, pancreas, small intestine, and kidneys). To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.
Measured: 1 day from injection of the tracers
SUV of tumors
The SUV of the above tracers in the primary and/or metastatic lesions of the included subjects. To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.
Measured: 1 day from injection of the tracers
Radiation dosimetry of tissues/organs
Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs. The following tissues were included: adrenals, brain, breasts, gallbladder, small intestine, upper and lower large intestine, stomach, heart contents, heart muscle, kidney, liver, lung, muscle, ovaries, pancreas, red marrow, trabecular and cortical bone, spleen, testes, thymus, thyroid, urinary bladder, and uterus. Dynamic imaging within one hour will be performed for this purpose.
Measured: 1 day from injection of the tracers
Radiation dosimetry of tumors
Measurement of absorbed radiation doses (Gy/MBq) to tumors. Dynamic imaging within one hour will be performed for this purpose.
Measured: 1 day from injection of the tracers
Radiation dosimetry of whole-body
Whole-body activity was measured using a large volume of interest (VOI) covering the entire subject.
Measured: 1 day from injection of the tracers
Diagnostic sensitivity
Sensitivity = (True Positives) / (True Positives + False Negatives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Measured: 30 days
Diagnostic specificity
Specificity = (True Negatives) / (True Negatives + False Positives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Measured: 30 days
Accuracy
Accuracy = (True Positives + True Negatives) / (Total Tests). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Measured: 30 days
Positive Predictive Value (PPV)
PPV = (True Positives) / (True Positives + False Positives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Measured: 30 days
Negative Predictive Value (NPV)
NPV = (True Negatives) / (True Negatives + False Negatives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Measured: 30 days
Secondary outcomes (5)
Trop2 immunoPET/CT in altering initial staging for patients with solid tumors
Assess the role of Trop2 immunoPET/CT in initial staging in terms of the number of metastases.
Measured: 3-6 months
Trop2 immunoPET/CT for postoperative surveillance for patients with solid tumors
Assess the role of Trop2 immunoPET/CT in surveillance in terms of the number of metastases, Trop2-derived tumor volume (Trop2-TV), and total lesion Trop2 uptake (Trop2-TLU).
Measured: 3-6 months
Trop2 immunoPET/CT for restaging for patients with solid tumors
Assess the role of Trop2 immunoPET/CT in restaging in terms of the number of metastases, Trop2-TV, and Trop2-TLU.
Measured: 3-6 months
Trop2 immunoPET/CT in evaluating treatment responses
We will also investigate the role of Trop2 immunoPET/CT in predicting and evaluating the treatment efficacy in patients with solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer). The treatment regimens vary for different tumor types but involve chemotherapy, molecularly targeted therapies, immunotherapies (e.g. PD-1/PD-L1 inhibitors), and cell therapies.
Measured: 1-2 years
Whole-body tumor burden（Trop2/PSMA-TV and TL-Trop2/PSMA）
For patients with prostate cancer or suspected prostate cancer, we will investigate the association between Trop2-derived and PSMA-derived volumetric parameters by correlating their respective values obtained from [18F]AlF-RESCA-RT4 and PSMA PET
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start23 Dec 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies 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 2/3
- 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
- Jianjun Liu, Ph.D. & M.D., Study chair, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong UniversityWeijun Wei, Ph.D. & M.D., Principal investigator, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851663
- Sponsor's protocol ID
- LY2024-307-A
- Status last verified
- May 2026
- First submitted
- 24 Feb 2025
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Long X, An S, Nian X, Xu D, Wei W, Lan X, Dong L, Jiang D. Trop2 immuno-PET/CT imaging of prostate cancer: a proof-of-concept translational study. BMC Med. 2025 Dec 31;24(1):66. doi: 10.1186/s12916-025-04589-8.
PubMed 41469668
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trop2-targeted immunoPET Imaging of Solid Tumors
- ClinicalTrials.gov ID
- NCT06851663
- Acronym / sponsor ID
- LY2024-307-A
- Conditions
- Solid Tumor, Solid Carcinoma, Uroepithelial Carcinoma, Bladder Cancer, Prostate Cancer, Lung Cancer
- Keywords
- Trophoblast cell surface antigen 2 (Trop2), ImmunoPET, Solid Tumor
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Feb 2025 (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 study aims to establish and optimize the trophoblast cell surface antigen 2 (Trop2)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) will be evaluated.
Detailed description
Histologically confirmed solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer), or patients with suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) indicated by conventional diagnostic imaging will be included. Patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation.For patients with prostate cancer or suspected prostate cancer, head-to-head comparisons with PSMA PET are still needed.
Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.05-0.1 mCi/kg). The uptake of imaging tracers in tumors 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 assess the diagnostic efficacy. The correlation between lesion uptake and Trop2 expression level determined by immunohistochemistry staining will be further analyzed. The primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18F-FDG PET/CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trop2-targeted immunoPET imaging | Experimental | Drug: [68Ga]Ga-NOTA-T4, Drug: [68Ga]Ga-NOTA-RT4, Drug: [18F]F-RESCA-T4, Drug: [18F]F-RESCA-RT4Enrolled patients will undergo a Trop2-targeted 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 year-old and of either sex
- Histologically confirmed diagnosis of solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) or suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) by diagnostic imaging;
- Capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (ICF) and this protocol.
Key exclusion criteria (3 listed)
- Pregnancy；
- Severe hepatic and renal insufficiency;
- Allergic to 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-NOTA-T4Also: [68Ga]T4Enrolled patients will receive 0.05-0.1 mCi/kg of [68Ga]Ga-NOTA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-T4 injection. | Drug | Trop2-targeted immunoPET imaging |
| [68Ga]Ga-NOTA-RT4Also: [68Ga]RT4Enrolled patients will receive 0.05-0.1 mCi/kg of [68Ga]Ga-NOTA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-RT4 injection. | Drug | Trop2-targeted immunoPET imaging |
| [18F]F-RESCA-T4Also: [18F]T4Enrolled patients will receive 0.05-0.1 mCi/kg of [18F]F-RESCA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-T4 injection. | Drug | Trop2-targeted immunoPET imaging |
| [18F]F-RESCA-RT4Also: [18F]RT4Enrolled patients will receive 0.05-0.1 mCi/kg of [18F]F-RESCA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-RT4 injection. | Drug | Trop2-targeted immunoPET imaging |
Primary outcome
Biodistribution-Standardized uptake value (SUV) of normal tissues and organs.
Time frame: 1 day from injection of the tracers
Measurement of the overall biodistribution of the above tracers in normal tissues and organs (bladder (after voiding), background (pelvic fat), blood, brain, salivary and lacrimal glands, lung, liver, spleen, pancreas, small intestine, and kidneys). To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.
SUV of tumors
Time frame: 1 day from injection of the tracers
The SUV of the above tracers in the primary and/or metastatic lesions of the included subjects. To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.
Radiation dosimetry of tissues/organs
Time frame: 1 day from injection of the tracers
Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs. The following tissues were included: adrenals, brain, breasts, gallbladder, small intestine, upper and lower large intestine, stomach, heart contents, heart muscle, kidney, liver, lung, muscle, ovaries, pancreas, red marrow, trabecular and cortical bone, spleen, testes, thymus, thyroid, urinary bladder, and uterus. Dynamic imaging within one hour will be performed for this purpose.
Radiation dosimetry of tumors
Time frame: 1 day from injection of the tracers
Measurement of absorbed radiation doses (Gy/MBq) to tumors. Dynamic imaging within one hour will be performed for this purpose.
Radiation dosimetry of whole-body
Time frame: 1 day from injection of the tracers
Whole-body activity was measured using a large volume of interest (VOI) covering the entire subject.
Diagnostic sensitivity
Time frame: 30 days
Sensitivity = (True Positives) / (True Positives + False Negatives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Diagnostic specificity
Time frame: 30 days
Specificity = (True Negatives) / (True Negatives + False Positives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Accuracy
Time frame: 30 days
Accuracy = (True Positives + True Negatives) / (Total Tests). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Positive Predictive Value (PPV)
Time frame: 30 days
PPV = (True Positives) / (True Positives + False Positives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
Negative Predictive Value (NPV)
Time frame: 30 days
NPV = (True Negatives) / (True Negatives + False Negatives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
5 secondary outcomes
Trop2 immunoPET/CT in altering initial staging for patients with solid tumors
Time frame: 3-6 months
Trop2 immunoPET/CT for postoperative surveillance for patients with solid tumors
Time frame: 3-6 months
Trop2 immunoPET/CT for restaging for patients with solid tumors
Time frame: 3-6 months
Trop2 immunoPET/CT in evaluating treatment responses
Time frame: 1-2 years
Whole-body tumor burden（Trop2/PSMA-TV and TL-Trop2/PSMA）
Time frame: 30 days
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 29 May 2026.
- Derived from this study: PubMed 41469668Long X, An S, Nian X, Xu D, Wei W, Lan X, Dong L, Jiang D. Trop2 immuno-PET/CT imaging of prostate cancer: a proof-of-concept translational study. BMC Med. 2025 Dec 31;24(1):66. doi: 10.1186/s12916-025-04589-8.
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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.
Jianjun Liu, Ph.D. & M.D. study chair
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Weijun Wei, Ph.D. & M.D. principal investigator
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 Phase 2/3 study testing [68Ga]Ga-NOTA-T4, [68Ga]Ga-NOTA-RT4 and [18F]F-RESCA-T4 in people with Solid Tumor and Solid Carcinoma, 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 3 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 29 May 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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-Standardized uptake value (SUV) of normal tissues and organs. (time frame: 1 day from injection of the tracers). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06851663, which also lists 1 linked publication.
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 29 May 2026.