A Phase 2/3 interventional study of [68Ga]Ga-NOTA-T4 and [68Ga]Ga-NOTA-RT4 in Solid Tumor, Solid Carcinoma and Uroepithelial Carcinoma, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by RenJi Hospital · Phase 2/3, Interventional, and Diagnostic
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.
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.
716 studies on the registry are indexed under Carcinoma, Transitional Cell; 201 are open to participants now.
This study's planned enrollment of 400 is above the median of 49 across 549 interventional studies indexed under Carcinoma, Transitional Cell.
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Exclusion Criteria:
Enrolled patients will undergo a Trop2-targeted immunoPET/CT scanning.
Drug: [68Ga]Ga-NOTA-T4 · Drug: [68Ga]Ga-NOTA-RT4 · Drug: [18F]F-RESCA-T4 · Drug: [18F]F-RESCA-RT4
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.
Also known as: [68Ga]T4
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.
Also known as: [68Ga]RT4
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.
Also known as: [18F]T4
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.
Also known as: [18F]RT4
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
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
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
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
Radiation dosimetry of whole-body
Whole-body activity was measured using a large volume of interest (VOI) covering the entire subject.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 30 days
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