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Clinical Application Study of PET/CT for Differential Diagnosis of Non-small Cell Lung Cancer

ConditionsLung CancerLung DiseasesLung NeoplasmsLung Cancer MetastaticLung Inflammation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • [68Ga]Ga-NOTA-T4

    Drug

    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-RT4

    Drug

    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-T4

    Drug

    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-RT4

    Drug

    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-EPCD6

    Drug

    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-EPCD6

    Drug

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: ImmunoPET imaging in patients with lung cancersExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
1 day from injection of the tracers

Secondary outcomes

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.

Time frame
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).

Time frame
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.

Time frame
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.

Time frame
1-2years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov
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