Bladder Cancer, Cervical Cancer, Cholangiocarcinoma, Endometrial Cancer, Head and Neck Cancer, Liver Cancer, Lung Cancer, Nasopharyngeal Cancer, Ovarian Cancer, Prostate Cancer, Solid Carcinoma, Solid Tumor, Thyroid Cancer, Uroepithelial Carcinoma
Conditions
Keywords
Trophoblast cell surface antigen 2 (Trop2), ImmunoPET, Solid Tumor
Brief 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 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.
Interventions
DRUG[68Ga]Ga-NOTA-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.
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.
DRUG[18F]F-RESCA-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.
DRUG[18F]F-RESCA-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.
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Pregnancy； * Severe hepatic and renal insufficiency; * Allergic to single-domain antibody radiopharmaceuticals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution-Standardized uptake value (SUV) of normal tissues and organs. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trop2 immunoPET/CT in altering initial staging for patients with solid tumors | 3-6 months | Assess the role of Trop2 immunoPET/CT in initial staging in terms of the number of metastases. |
| Trop2 immunoPET/CT for postoperative surveillance for patients with solid tumors | 3-6 months | 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). |
| Trop2 immunoPET/CT for restaging for patients with solid tumors | 3-6 months | Assess the role of Trop2 immunoPET/CT in restaging in terms of the number of metastases, Trop2-TV, and Trop2-TLU. |
| Trop2 immunoPET/CT in evaluating treatment responses | 1-2 years | 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. |
| Whole-body tumor burden（Trop2/PSMA-TV and TL-Trop2/PSMA） | 30 days | 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 |
Countries
China
Contacts
CONTACTWeijun Wei, Ph.D. & M.D.
STUDY_CHAIRJianjun Liu, Ph.D. & M.D.
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
PRINCIPAL_INVESTIGATORWeijun Wei, Ph.D. & M.D.
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Outcome results
None listed