Trop2-targeted immunoPET Imaging of Solid Tumors

NCT06851663 | Recruiting Phase 2

• 1 other identifier: LY2024-307-A
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Prostate Cancer; Nasopharyngeal Cancer; Liver Cancer; Cholangiocarcinoma; Ovarian Cancer; Cervical Cancer; Thyroid Cancer; Head and Neck Cancer; Lung Cancer; Endometrial Cancer; Solid Tumor; Solid Carcinoma; Uroepithelial Carcinoma

Keywords

Trophoblast cell surface antigen 2 (Trop2); ImmunoPET; Solid Tumor

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  30 days

Secondary Outcomes (4)

• Trop2 immunoPET/CT in altering initial staging for patients with solid tumors

  3-6 months

• Trop2 immunoPET/CT for postoperative surveillance for patients with solid tumors

  3-6 months

• Trop2 immunoPET/CT for restaging for patients with solid tumors

  3-6 months

• Trop2 immunoPET/CT in evaluating treatment responses

  1-2 years

Study Arms (1)

Trop2-targeted immunoPET imaging

EXPERIMENTAL

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

Interventions

[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.

Also known as: [68Ga]T4

Trop2-targeted immunoPET imaging

[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.

Also known as: [68Ga]RT4

Trop2-targeted immunoPET imaging

[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.

Also known as: [18F]T4

Trop2-targeted immunoPET imaging

[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.

Also known as: [18F]RT4

Trop2-targeted immunoPET imaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy；
• Severe hepatic and renal insufficiency;
• Allergic to single-domain antibody radiopharmaceuticals.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, 200127, China

RECRUITING

Related Publications (1)

• Long X, An S, Nian X, Xu D, Wei W, Lan X, Dong L, Jiang D. Trop2 immuno-PET/CT imaging of prostate cancer: a proof-of-concept translational study. BMC Med. 2025 Dec 31;24(1):66. doi: 10.1186/s12916-025-04589-8.

  PMID: 41469668 DERIVED

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Urinary Bladder Neoplasms; Prostatic Neoplasms; Lung Neoplasms; Nasopharyngeal Neoplasms; Liver Neoplasms; Cholangiocarcinoma; Ovarian Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Thyroid Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Thyroid Diseases

Study Officials

• Jianjun Liu, Ph.D. & M.D.

  Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  STUDY CHAIR

• Weijun Wei, Ph.D. & M.D.

  Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weijun Wei, Ph.D. & M.D.

CONTACT

15000083153; wwei@shsmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: December 23, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

CN (1)