Lung CancerNCT07026110
Clinical Application Study of PET/CT for Differential Diagnosis of Non-small Cell Lung Cancer
A study testing [68Ga]Ga-NOTA-T4, [68Ga]Ga-NOTA-RT4 and [18F]F-RESCA-T4 in people with Lung Cancer and Lung Diseases, run by RenJi Hospital at 1 site in China.
Trial summary
This study aims to explore the efficacy of Trop2, EpCAM-specific PET/CT imaging for noninvasive visualization of Trop2 or EpCAM expression levels in non-small cell lung cancer; and to explore the differences between novel target-specific PET/CT examinations and conventional 18F-FDG PET/CT in the diagnosis and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Lung Diseases, Lung Neoplasms
- 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
- 100 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2024to 31 Oct 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years;
- Imaging studies suspecting non-small cell lung cancer;
- Solid lung nodules (≥8 mm in diameter) diagnosed by chest ct, which are subject to 18F-FDG PET/CT and surgical resection/biopsy of lung nodules according to the NCCN guideline specifications for NSCLC in the 2024 edition;
- Patients or family members agreed to participate in this clinical study and signed an informed consent form.
Who cannot join
- Women during pregnancy and lactation;
- Persons with a history of surgery and trauma that significantly affects metabolic distribution and anatomical structure;
- Persons with severe other systemic diseases or known hypersensitivity to humanized monoclonal antibody products;
- Patient is unable to cooperate in completing the PET/CT examination;
- Patient has participated in other clinical studies within the past year that have resulted in radiation exposures in excess of an effective dose of 50 mSv, in addition to the radiation exposures anticipated from participation in this clinical study;
- Patient should not participate in this clinical trial in the opinion of the investigator.
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
Wenzhi Jia, 18317076979, jwzdata@126.com
About this study
This study aims to explore the efficacy of Trop2, EpCAM-specific PET/CT imaging for noninvasive visualization of Trop2 or EpCAM expression levels in non-small cell lung cancer; and to explore the differences between novel target-specific PET/CT examinations and conventional 18F-FDG PET/CT in the diagnosis and differential diagnosis of solid lung nodules.
Read the detailed description
A solid lung nodule was initially diagnosed as non-small cell lung cancer by chest CT. Patients with lung nodules subjected to 18F-FDG PET/CT with surgical resection/biopsy. Patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation.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 and EpCAM 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.
- Being tested
- [68Ga]Ga-NOTA-T4, [68Ga]Ga-NOTA-RT4, [18F]F-RESCA-T4, [18F]F-RESCA-RT4, [18F]F-RESCA-EPCD6
- Keywords
- Trophoblast cell surface antigen 2 (Trop2), Epithelial cell adhesion molecule(EpCAM), ImmunoPET, Lung tumor
- Medical subject headings
- Lung Neoplasms, Lung Diseases, Pneumonia, Colorectal Cancer, Hereditary Nonpolyposis, Type 8
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.
[18F]F-RESCA-EPCD6Drug
Also called [18F]F-EPCD6
Enrolled patients will receive 0.05-0.1 mCi/kg of [18F]F-RESCA-EPCD6. ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-EPCD6 injection.
[68Ga]Ga-NOTA-EPCD6Drug
Also called [18F]F-EPCD6
Enrolled patients will receive 0.05-0.1 mCi/kg of [68Ga]Ga-NOTA-EPCD6. ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-EPCD6 injection.
| Study group | Role | What they receive |
|---|---|---|
| ImmunoPET imaging in patients with lung cancers | Experimental | Enrolled lung cancer patients will undergo a Trop2/EpCAM-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; Drug: [18F]F-RESCA-EPCD6; Drug: [68Ga]Ga-NOTA-EPCD6 |
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 and EpCAM 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 and EpCAM 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 and EpCAM 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 and EpCAM 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 and EpCAM 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)
ImmunoPET/CT in altering initial staging for patients with lung tumors
Assess the role of Trop2 and EpCAM immunoPET/CT in initial staging in terms of the number of metastases.
Measured: 3-6 months
ImmunoPET/CT for postoperative surveillance for patients with lung tumors
Assess the role of Trop2 and EpCAMimmunoPET/CT in surveillance in terms of the number of metastases, Trop2 and EpCAM-derived tumor volume (Trop2 and EpCAM-TV), and total lesion Trop2 uptake (Trop2 and EpCAM-TLU).
Measured: 3-6 months
ImmunoPET/CT for restaging for patients with lung tumors
Assess the role of Trop2 and EpCAM immunoPET/CT in restaging in terms of the number of metastases, Trop2 and EpCAM-TV, and Trop2 and EpCAM-TLU.
Measured: 3-6 months
ImmunoPET/CT in evaluating treatment responses
We will also investigate the role of Trop2 and immunoPET/CT in predicting and evaluating the treatment efficacy in patients with lung tumors. The treatment regimens involve chemotherapy, molecularly targeted therapies, immunotherapies (e.g. PD-1/PD-L1 inhibitors), and cell therapies.
Measured: 1-2years
ImmunoPET/CT in identifying inflammation and tumors in the lungs
We will also investigate the role of Trop2 and immunoPET/CT in identifying the benign and malignant nature of pulmonary lesions and hilar and mediastinal lymph nodes
Measured: 1 day from injection of the tracers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start23 Dec 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- 100 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
- NCT07026110
- Sponsor's protocol ID
- LY2024-329-C
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application Study of PET/CT for Differential Diagnosis of Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07026110
- Acronym / sponsor ID
- LY2024-329-C
- Keywords
- Trophoblast cell surface antigen 2 (Trop2), Epithelial cell adhesion molecule(EpCAM), ImmunoPET, Lung tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 18 Jun 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 explore the efficacy of Trop2, EpCAM-specific PET/CT imaging for noninvasive visualization of Trop2 or EpCAM expression levels in non-small cell lung cancer; and to explore the differences between novel target-specific PET/CT examinations and conventional 18F-FDG PET/CT in the diagnosis and differential diagnosis of solid lung nodules.
Detailed description
A solid lung nodule was initially diagnosed as non-small cell lung cancer by chest CT. Patients with lung nodules subjected to 18F-FDG PET/CT with surgical resection/biopsy. Patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation.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 and EpCAM 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 |
|---|---|---|
| ImmunoPET imaging in patients with lung cancers | Experimental | Drug: [68Ga]Ga-NOTA-T4, Drug: [68Ga]Ga-NOTA-RT4, Drug: [18F]F-RESCA-T4, Drug: [18F]F-RESCA-RT4, Drug: [18F]F-RESCA-EPCD6, Drug: [68Ga]Ga-NOTA-EPCD6Enrolled lung cancer patients will undergo a Trop2/EpCAM-targeted immunoPET/CT scanning. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years;
- Imaging studies suspecting non-small cell lung cancer;
- Solid lung nodules (≥8 mm in diameter) diagnosed by chest ct, which are subject to 18F-FDG PET/CT and surgical resection/biopsy of lung nodules according to the NCCN guideline specifications for NSCLC in the 2024 edition;
- Patients or family members agreed to participate in this clinical study and signed an informed consent form.
Key exclusion criteria (6 listed)
- Women during pregnancy and lactation;
- Persons with a history of surgery and trauma that significantly affects metabolic distribution and anatomical structure;
- Persons with severe other systemic diseases or known hypersensitivity to humanized monoclonal antibody products;
- Patient is unable to cooperate in completing the PET/CT examination;
- Patient has participated in other clinical studies within the past year that have resulted in radiation exposures in excess of an effective dose of 50 mSv, in addition to the radiation exposures anticipated from participation in this clinical 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]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 | ImmunoPET imaging in patients with lung cancers |
| [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 | ImmunoPET imaging in patients with lung cancers |
| [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 | ImmunoPET imaging in patients with lung cancers |
| [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 | ImmunoPET imaging in patients with lung cancers |
| [18F]F-RESCA-EPCD6Also: [18F]F-EPCD6Enrolled patients will receive 0.05-0.1 mCi/kg of [18F]F-RESCA-EPCD6. ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-EPCD6 injection. | Drug | ImmunoPET imaging in patients with lung cancers |
| [68Ga]Ga-NOTA-EPCD6Also: [18F]F-EPCD6Enrolled patients will receive 0.05-0.1 mCi/kg of [68Ga]Ga-NOTA-EPCD6. ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-EPCD6 injection. | Drug | ImmunoPET imaging in patients with lung cancers |
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 and EpCAM 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 and EpCAM 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 and EpCAM 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 and EpCAM 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 and EpCAM immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
5 secondary outcomes
ImmunoPET/CT in altering initial staging for patients with lung tumors
Time frame: 3-6 months
ImmunoPET/CT for postoperative surveillance for patients with lung tumors
Time frame: 3-6 months
ImmunoPET/CT for restaging for patients with lung tumors
Time frame: 3-6 months
ImmunoPET/CT in evaluating treatment responses
Time frame: 1-2years
ImmunoPET/CT in identifying inflammation and tumors in the lungs
Time frame: 1 day from injection of the tracers
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 18 Jun 2025.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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-NOTA-T4, [68Ga]Ga-NOTA-RT4 and [18F]F-RESCA-T4 in people with Lung Cancer and Lung Diseases, 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 4 inclusion and 6 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 18 Jun 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 (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?
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 18 Jun 2025.