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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, 200127

    Weijun Wei, 15000083153, wwei@shsmu.edu.cn

    Wenzhi Jia, 18317076979, jwzdata@126.com

    Recruiting

Other trials in China

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 groups in NCT07026110
Study groupRoleWhat they receive
ImmunoPET imaging in patients with lung cancersExperimentalEnrolled 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted18 Jun 2025
  2. Study start23 Dec 2024
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

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)
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

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.

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